BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    MDR report key: 3232492 · Received July 18, 2013

    Report

    Report Number
    1823260-2013-04315
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 23, 2013
    Report Date
    August 26, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K113137
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 NANO SYSTEM BLOOD GLUCOSE RESULTS 380 MG/DL AND 170 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334874 ACCU-CHEK ® SMARTVIEW TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 471509

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR HUMULIN| CANE| ASPIRIN