BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 11922194 · Received June 2, 2021

    Report

    Report Number
    2245578-2021-00050
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    May 24, 2021
    Report Date
    September 29, 2021
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749005519
    PMA / PMN Number
    K053110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON (B)(6) 2021. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOT PASSED FINISHED GOODS RELEASE CRITERIA. ALTHOUGH RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AG, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE, RETURNED CARTRIDGE TESTING DID NOT MEET THE CRITERION FOR SUPPRESSED RESULTS. A PREVIOUSLY IDENTIFIED UNRELATED DEFICIENCY IS BEING INVESTIGATED IN QUALITY RECORD (QR) 791655 FOR THE SUPPRESSED RESULTS. ADDITIONALLY, LOT H21080 HAS AN UNRELATED DEFICIENCY FOR ICA POINTS OUTSIDE TOTAL ALLOWABLE ERROR (EA) IN WHOLE BLOOD (WB) AND AS WELL AS AN UNRELATED DEFICIENCY FOR ICA STAR-OUTS WHICH IS BEING INVESTIGATED IN QR 780359. QR-787319 IS ALSO INVESTIGATING A PREVIOUS DEFICIENCY.

    Description of Event or Problem · 0

    NA.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT SODIUM RESULTS ON A (B)(6) YEAR OLD FEMALE PATIENT WITH HEART FAILURE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819295 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H21080 10054749005519

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR