BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 3033486 · Received April 3, 2013

    Report

    Report Number
    1823260-2013-02027
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 14, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    CALLER REPORTED TAKING 1 UNIT OF HUMALOG BASED UPON A COMPACT PLUS SYSTEM BLOOD GLUCOSE RESULT OF 142 MG/DL AT 11:00 PM. SAME SYSTEM RETEST RESULT AT 11:05 PM WAS 309 MG/DL. SAME SYSTEM RETEST RESULT WITHIN 10 MINUTES WAS "IN THE HIGH 200S" MG/DL. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137283 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20734541

    Patients

    Seq Age Sex Outcome Treatment
    1 074 YR ATENOLOL| DORZOLAMIDE| LANTUS| COSARTAN| ZOLPIDEM| HUMALOG| ASPIRIN| AMLODIPINE| SYNTHROID| BRIMONIDINE