BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 3944416 · Received July 18, 2014

    Report

    Report Number
    1823260-2014-05364
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 19, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 88 MG/DL, 80 MG/DL, AND 30 MG/DL. CUSTOMER RELT FINE DURING THE WHOLE TIME. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421416 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20809454

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR ACCUNEB INHALER| GEMFIBROZIL| MACHINE TO CHECK OXYGEN WITH| MUCINEX| TRAMADOL HCL| TOPIRAMATE| METFORMIN| ZYRTEC| TRACH| CONCENTRATOR FOR OXYGEN MACHINE| ANOTHER MACHINE THAT GIVES COOL AIR FOR| PRILOSEC| DOXAZOSIN MESYLATE| POTASSIUM CHLORIDE| LASIX| MIRALAX| NEBULIZER