BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 19568885 · Received June 19, 2024

    Report

    Report Number
    2245578-2024-00120
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    June 12, 2024
    Report Date
    August 7, 2024
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JPI
    PMA / PMN Number
    K183680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 07-AUG-2024. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOT PASSED FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AN, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE, EXCEPT FOR POINTS OUTSIDE OF TOTAL ALLOWABLE ERROR (EA) LIMITS FOR IONIZED CALCIUM (ICA) IN WHOLE BLOOD (WB). ALTHOUGH NO POINTS OUTSIDE EA WERE OBSERVED IN RETURNED CARTRIDGE TESTING, AS PER Q04.01.003 REV. AN, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE, A MINIMUM SAMPLE SIZE OF 17 IS REQUIRED TO DETERMINE ACCEPTANCE AGAINST EA CRITERIA; RETURNED CARTRIDGE TESTING PASSED ACCEPTANCE CRITERIA IN Q04.01.003 REV. AN, APPENDIX 1 FOR SUPPRESSED RESULTS. A DEFICIENCY HAS BEEN IDENTIFIED FOR CHEM8+ LOT H24040A AND WILL BE INVESTIGATED THROUGH QUALITY RECORD (QR) 990766.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT POTASSIUM RESULTS ON AN 66 YEAR OLD FEMALE PATIENT WITH ATRIAL FIB, & EDEMA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED POTASSIUM SAMPLE I-STAT (B)(6) 2024 10:40 10:41 >9 MMOL/L VENIPUNCTURE A, I-STAT (B)(6) 2024 12:20 12:37 3.7 MMOL/L VENIPUNCTURE B. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672750 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JPI ABBOTT POINT OF CARE NA H24040A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female