BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT1 ANALYZER, IMMUNO READY

    MDR report key: 3234642 · Received July 18, 2013

    Report

    Report Number
    2245578-2013-00082
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    May 17, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CGA
    PMA / PMN Number
    K001387
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, ABBOTT POINT OF CARE (APOC) DISTRIBUTOR REPAIR CENTER WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER SN (B)(4) YIELDED QUALITY CHECK CODE 48 WHILE TESTING CARTRIDGES AND SIMULATOR. THE ANALYZER WAS RETURNED FOR REPAIR AND DURING FAILURE ANALYSIS A BURNT CAPACITOR (C13) WAS DISCOVERED. THE ANALYZER WAS RETURNED AND HAD BEEN OPERATING WITH A GREEN (NON-FUSED) BATTERY CARRIER. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335142 I-STAT1 ANALYZER, IMMUNO READY I-STAT1 ANALYZER CGA ABBOTT POINT OF CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1