|ABBOTT POINT OF CARE, INC.||400 COLLEGE ROAD EAST
PRINCETON, NJ 08540
|T: +1 609 454 9000
F: +1 609 419 9370
|PRODUCT NAME||LIST NUMBER||PRODUCT NAME||LIST NUMBER|
|i-STAT CG8+ cartridges||03P88-25||i-STAT EG7+ cartridge||03P76-25|
Dear Valued Abbott Point of Care Customer,
This letter contains important information regarding the i-STAT CG8+ and EG7+ cartridges noted above. If you are using these cartridges, your facility may be impacted, and further review and action may be required.
Abbott Point of Care (APOC) is communicating this information to all potentially impacted customers. Please review the information below as your attention to this information is required. Note: information in this letter is lot number specific.
The i-STAT CG8+ cartridge contains eight measured tests (sodium, potassium, ionized calcium, pH, p CO2, pO2, glucose and hematocrit) and the i-STAT EG7+ cartridge contains seven measured tests (sodium, potassium, ionized calcium, pH, pCO2, p O2, and hematocrit).
The test for ionized calcium, as part of the i-STAT System, is intended for use in the in vitro quantification of ionized calcium in arterial, venous, or capillary whole blood.
The i-STAT CG8+ and EG7+ cartridge Instructions for Use (IFU) indicate that these cartridges can be stored for 2 months at room temperature (18 to 30° C). Abbott routinely tests performance of i-STAT cartridges, including stability testing of the i-STAT CG8+ and EG7+ cartridges at various time intervals after storage in the refrigerator and at 30°C.
Through this internal testing process after storage at 30°C for 14 days, Abbott Point of Care observed approximately 5.2% of cartridges reporting higher than expected reported reuslts for ionized calcium. Abbott Point of Care observed ionized calcium on some i-STAT CG8+ or EG7+ cartridges may exhibit higher than expected reported results when stored at the room temperature (18 to 30° C) for periods of time in excess of:
Abbott Point of Care has not observed higher than expected reported results for ionized calcium test when i-STAT CG8+ and EG7+ cartridges are removed from refrigerated storage and warmed to room temperature for use within the number of days indicated above.
Abbott Point of Care has not observed this issue for any tests on the i-STAT CG8+ or EG7+ other than the ionized calcium test.
Abbott Point of Care is communicating this information to potentially impacted customers. Clinicians should be advised to consider a patient's signs, symptoms, history, and results of other diagnostic tests when interpreting the ionized calcium results form these cartridges. If the results do not match the patient's clinical presentation, the patient sample should be retested using an alternate i-STAT cartridge or test method. Treatment of falsely high ionized calcium may result in harm, by precipitating hypocalcemia. Abbott Point of Care has determined that the overall likelihood of harm associated with this issue is rare. The Abbott Point of Care has not received any reports of patient harm associated with this issue. The most common symptoms of hypocalcemia include paresthesia, muscle spasms, cramps, tetany circumoral numbness, and seizures. Although improbable, in the most extreme cases, hypocalcemia could potentially result in sudden cardiac death. This action has been communicated to the U.S. Food and Drug Administration.
Our records show that your facility is an i-STAT CG8+ or EG7+ cartridge user. While Abbott Point of Care continues to investigate this issue, if reporting ionized calcium is required, it is recommended that the i-STAT CG8+ and EG7+ cartridges be used only:
If your facility is unable to manage to the recommended action outlined above, Abbott Point of Care recommends that your facility disable and not report the ionized calcium test on the i-STAT CG8+ and EG7+ cartridges and use an alternate i-STAT cartridge for reporting ionized calcium. Pleaes see additional information below on how to disable the ionized calcium test for these cartridges.
Please confirm receipt and understanding of this communication by responding to the business reply form included with this letter.
Additional informaton regarding potential solutions will be provided separately by APOC. If you have forwarded any i-STAT CG8 + and EG7+ cartridges to another facility, we request that you please provide a copy of this letter to them.
We are providing, as an attachment, a list of the potentially impacted i-STAT CG8+ and EG7+ cartridge lots that have been distributed as of the date of this letter. Please continue to follow the recommended actions in this communication for all newly received i-STAT CG8+ and EG7+ lots until your facility receives an updated communication from Abbott Point of Care.
Your Abbott Point of Care sales and support team will be contacting you to review interim solutions for the challenges this communication may bring. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 1-844-256-9531 or via email at firstname.lastname@example.org
or visit the A bbott Point of Care website www.pointofcare.abbott. Additionally, please report any questions or concerns about the performance of the ionized calcium test on the i-STAT CG8+ and EG7+ cartridges to Abbott Point of Care Technical support at 1-800-366-8020 option 1, or via email at email@example.com .
If your facility decides to proceed with disabling the ionized calcium test, instructions are available on the Abbott Point of Care website www.pointofcare.abbott.
For instructions using i-STAT/DE, see i-STAT/DE Customizing Analyte Enable Options (ART 770545). For instruction using the i-STAT 1 analyzer directly see the i-STAT System Manual Section 2 – i-STAT Analyzer, (ART 714364) subsection Procedures for Customization using the analyzer keypad. If ionized calcium is interfaced through the Laboratory Information System (LIS) interface, disabling the analyte may require a change to the interface. Please contact your interface vendor for support.
Abbott Point of Care is fully committed to addressing this situation as a top priority and supporting you throughout this process. Abbott Point of Care will provide timely follow up communications when there is data to support longer storage at room temperature and after completion of the investigation.
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