BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    MDR report key: 3103419 · Received May 9, 2013

    Report

    Report Number
    1823260-2013-02866
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 13, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K113137
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION E4: NI - 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: 336 MG/DL, 125 MG/DL, 134 MG/DL, AND 136 MG/DL. CUSTOMER DRANK A LARGE GLASS OF ORANGE JUICE TO SELF-TREAT. 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
    203977 ACCU-CHEK ® SMARTVIEW TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 471215

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR OXYGEN AT BEDTIME| METFORMIN