BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT PLUS (GT)

    MDR report key: 3130694 · Received May 24, 2013

    Report

    Report Number
    1823260-2013-03199
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 2, 2013
    Report Date
    July 22, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K081389
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE CUSTOMER LEFT HER COMPACT PLUS METER OUT IN THE CAR AND THE TEMPERATURE DROPPED BELOW 30 DEGREES. CUSTOMER WENT TO GET METER ON (B)(6) 2013 AND NOTICED THAT THE BATTERY HAD EXPLODED AND THAT PART OF THE METER HAD MELTED AROUND THE BATTERY DOOR AND THE BACK OF THE METER. AFTER THE CUSTOMER DISCOVERED THE MELTED METER, SHE WAS ABLE TO RETRIEVE THE METER FROM THE CAR. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231376 ACCU-CHEK ® COMPACT PLUS (GT) BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1