BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2991531 · Received March 6, 2013

    Report

    Report Number
    1823260-2013-01357
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 11, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. WILL NOT BE RETURNED TO MANUFACTURER

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 120 MG/DL AND 375 MG/DL. RESULTS WERE FROM THE SAME FINGERSTICK. CUSTOMER SAID SHE TRIED ANOTHER TEST, BUT OBTAINED AN ERROR MESSAGE. CUSTOMER WAITED 20 MINUTES AND RETESTED AT HI (GREATER THAN 600 MG/DL). CUSTOMER WAS FEELING HYPERGLYCEMIC, BUT DID NOT TREAT HERSELF. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS; HOWEVER, CUSTOMER HAS DISCARDED STRIP VIAL. REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96107 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 034 YR UNSPECIFIED LONG ACTING INSULIN| ENALAPRIL| COREG| NOVOLOG