BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CARTRIDGE

    MDR report key: 17030559 · Received May 31, 2023

    Report

    Report Number
    2245578-2023-00063
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    May 24, 2023
    Report Date
    August 4, 2023
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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). THE INVESTIGATION WAS COMPLETED ON 01-AUG-2023. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOTS PASSED FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AK, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED FOR CG8+ CARTRIDGE LOTS W23046, L23090A, AND L23090B.

    Description of Event or Problem · 0

    ON 24-MAY-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CARTRIDGES (PRODUCT/LOT UNKNOWN) THAT YIELDED SUSPECTED DISCREPANT IONIZED HEMOGLOBIN RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. THERE WERE NO TEST/COLLECT TIMES PRESENTED WITH THE RESULTS. METHD DATE HGB SAMPLE I-STAT 24-MAY-2023 71 A I-STAT 24-MAY-2023 112 A LAB 24-MAY-2023 67 A 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
    1557435 I-STAT CARTRIDGE CARTRIDGE CHL ABBOTT POINT OF CARE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown