BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 3141991 · Received June 3, 2013

    Report

    Report Number
    1823260-2013-03297
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    February 6, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. STRIPS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    CALLER REPORTED COMPACT PLUS BLOOD GLUCOSE RESULTS OF 200 MG/DL, 102 MG/DL, AND 51 MG/DL MG/DL WITHIN 10 MINUTES. CALLER REPORTED ANOTHER, SEPARATE COMPARISON ON THE SAME SYSTEM OF 300 MG/DL AND 99-115 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT REPORTED. STRIPS ARE NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245407 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR PEPCID| BLOOD PRESSURE CUFF| VSL#3 PROBIOTIC| METFORMIN| MULTI-VITAMIN| LIPO-FLAVONOID (SUPPLEMENT)| TRILIPIX