BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT1 FUSO ANALYZER

    MDR report key: 3026067 · Received March 28, 2013

    Report

    Report Number
    2245578-2013-00051
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    July 5, 2010
    Report Date
    August 20, 2010
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCIDENT WAS IDENTIFIED FOLLOWING REVIEW OF THIRD PARTY MANUFACTURER GENERATED RECORDS AGAINST PROCEDURAL REQUIREMENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER #101158 WOULD NOT ACTIVATE. THE ANALYZER WAS RETURNED ON (B)(6) 2010 AND DURING FAILURE ANALYSIS CAPACITOR C4 ON THE MAIN PCB WAS FOUND SHORTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT. APOC HAS DETERMINED THAT THE IDENTIFIED COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128030 I-STAT1 FUSO ANALYZER I-STAT1 ANALYZER CGA ABBOTT POINT OF CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1