BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1834022 · Received September 14, 2010

    Report

    Report Number
    1823260-2010-05437
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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

    IT WAS REPORTING THAT THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS. TROUBLESHOOTING WAS PERFORMED. THE DEVICE RESTED AND IT HAD FROZEN DISPLAY. NO FURTHER INFO WAS PROVIDED.

    Description of Event or Problem · 1

    CALLER REPORTED COMPACT PLUS BLOOD GLUCOSE RESULTS OF 348 MG/DL AND 160 MG/DL WITHIN 1 MINUTE. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20725741

    Patients

    Seq Age Sex Outcome Treatment
    1 057 YR