BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 13536702 · Received February 15, 2022

    Report

    Report Number
    2245578-2022-00027
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    February 9, 2022
    Report Date
    May 2, 2022
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749000163
    PMA / PMN Number
    K053110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). TYPOGRAPHIC ERRORS NOTED DURING A REVIEW ON 28-APR-2022. CORRECTED INFORMATION: B5 PRODUCT INFORMATION: CHANGE FROM CG8+ TO CHEM8+. D1 BRAND NAME: CHANGE FROM CG8+ TO CHEM8+. D2 COMMON DEVICE NAME: CHANGE FROM CG8+, CHL TO CHEM8+ JGS. G4 PREMARKET IDENTIFICATION: CHANGE FROM K940918 TO K053110.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 23-FEB-2021. 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. AG, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. A PREVIOUS DEFICIENCY WAS IDENTIFIED FOR SUPPRESSED RESULTS AND IS BEING INVESTIGATED IN QUALITY RECORD (QR) (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT HEMATOCRIT RESULT OF 29% PCV ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION. I-STAT HCT 29% PCV, I-STAT CREA 0.7MG/DL, MANUAL HCT 45% PCV. 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.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379611 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H21357 10054749000163
    669883 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H21357 10054749000163

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown