BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    MDR report key: 3852232 · Received June 5, 2014

    Report

    Report Number
    1823260-2014-04068
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    June 26, 2014
    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

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

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY FELT AS THOUGH HE HAD LOW BLOOD GLUCOSE SYMPTOMS. HE TESTED AND RECEIVED A RESULT OF 171 MG/DL ON THE NANO SYSTEM. HE TESTED AGAIN WITHIN 10 MINUTES AND RECEIVED A RESULT OF 55 MG/DL. HE WAS ABLE TO SELF TREAT THE LOW BLOOD GLUCOSE BY EATING AND DRINKING. 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
    328775 ACCU-CHEK ® SMARTVIEW TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 472203

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR APIDRA| LEVEMIR