BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    MDR report key: 3120364 · Received May 20, 2013

    Report

    Report Number
    1823260-2013-03055
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 21, 2013
    Report Date
    July 25, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K113137
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 THE FOLLOWING RESULTS ON THE NANO SYSTEM WITHIN 10 MINUTES: 220 MG/DL, 147 MG/DL, AND 109 MG/DL. 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
    222497 ACCU-CHEK ® SMARTVIEW TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 471324

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED ORAL MEDICATION