BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT PLUS TEST DRUM

    MDR report key: 4266594 · Received November 20, 2014

    Report

    Report Number
    1823260-2014-09121
    Event Type
    Malfunction
    Date Received
    November 20, 2014
    Date of Event
    October 25, 2014
    Report Date
    January 8, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K113614
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY STRIP DRUM WAS RETURNED.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 1. "LO" (<20 MG/DL) AND 129 MG/DL 2. "LO" (<20 MG/DL) AND 153 MG/DL READINGS OF "LO" WERE NOT DUPLICATED. SETS OF READINGS WERE TAKEN ON DIFFERENT DAYS WITH THE SAME METER AND STRIP LOT. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECTED DEVICE AND STRIPS AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753093 ACCU-CHEK ® COMPACT PLUS TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20809551

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR METFORMIN 500 MG| SIMVASTATIN