BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 12341245 · Received August 19, 2021

    Report

    Report Number
    2245578-2021-00065
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 27, 2021
    Report Date
    October 26, 2021
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749005519
    PMA / PMN Number
    K183688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 22-OCT-2021. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. FOR CHEM8+ CARTRIDGE LOT H21152B, OTHER THAN FOR TCO2 WHEN TESTING WITH CV5TRI, RETAINED CARTRIDGE TEST RESULTS MET ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AG, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE WITH RESPECT TO RATE OF RESULTS OUTSIDE EA LIMITS. TESTING WITH CV4B MET ALL ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV.AG, SO NO DEFICIENCY HAS BEEN DETERMINED WITH RESPECT TO TCO2 PERFORMANCE. DUE TO AN ELEVATED RATE OF ICA STAR OUTS WHEN TESTING WITH TRICONTROLS CALIBRATION VERIFICATION LEVEL 5 (CV5TRI), RETAINED CARTRIDGE TEST RESULTS DID NOT MEET THE ACCEPTANCE CRITERION FOUND IN APPENDIX 1 OF Q04.01.003 REV.AG WITH RESPECT TO RATE OF SUPPRESSED RESULTS. THE LOT HAS PREVIOUSLY BEEN DETERMINED TO DEFICIENT FOR ICA STAR-OUTS AND IT BEING INVESTIGATION UNDER QUALITY RECORD (QR) 780359. RETURNED TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AG, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. A PREVIOUSLY IDENTIFIED UNRELATED DEFICIENCY HAS BEEN DETERMINED FOR CHEM8+ CARTRIDGE LOT H21152B.

    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 HEMATOCRIT RESULTS ON A (B)(6) YEAR OLD FEMALE PATIENT WITH HYPOTENSION. 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 PATIENT WAS NOT TRANSFUSED BASED ON THE I-STAT RESULT. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240845 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H21152B 10054749005519

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR