BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 3063461 · Received April 17, 2013

    Report

    Report Number
    1823260-2013-02338
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 23, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. REFERENCE THE FOLLOWING MEDWATCHES WITH PATIENT IDENTIFIERS FOR THE FOLLOWING SYSTEMS: (B)(6) - COMPACT PLUS SYSTEM (B)(6) - NANO SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 304 MG/DL AND 83 MG/DL. CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE TWO SYSTEMS WITHIN 10 MINUTES: 471 MG/DL, 183 MG/DL (COMPACT PLUS) AND 132 MG/DL (NANO). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165705 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20734043

    Patients

    Seq Age Sex Outcome Treatment
    1 028 YR HUMAN NOVOLIN| NPH NOVOLIN| PRENATAL VITAMINS