BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT1 ANALYZER, IMMUNO READY

    MDR report key: 4210458 · Received October 29, 2014

    Report

    Report Number
    2245578-2014-00078
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 01/19/2015. THE FAILURE WAS DUE TO A DEFECTIVE TANTALUM CAPACITOR.

    Description of Event or Problem · 1

    NA.

    Description of Event or Problem · 1

    ON (B)(6) 2014, AN ABBOTT POINT OF CARE (APOC) DISTRIBUTOR WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER SN (B)(4) WOULD NOT ACTIVATE. WHEN THE BATTERIES WERE REPLACED VISIBLE SMOKE CAME FROM THE BATTERY COMPARTMENT. THE CUSTOMER STATES THE ANALYZER WAS OPERATING WITH A RED (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. HOWEVER, THE CUSTOMER STATES THAT A RED FUSED BATTERY CARRIER WAS BEING USED. THEREFORE THE ANALYZER IS UNLIKELY TO BECOME HOT TO TOUCH. THE PRODUCT WAS REPLACED AND RETURNING FOR INVESTIGATION. 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
    692536 I-STAT1 ANALYZER, IMMUNO READY I-STAT1 ANALYZER CGA ABBOTT POINT OF CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1