BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT PLUS TEST DRUM

    MDR report key: 3840560 · Received May 30, 2014

    Report

    Report Number
    1823260-2014-03877
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 3, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 22 MG/DL AND 93 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318844 ACCU-CHEK ® COMPACT PLUS TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20809056

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR NOVOLOG 70/30 FLEX PEN| SYNTHROID| ZOLOFT| LORAZEPAM| WARFARIN| PACERONE| LIPITOR