BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    MDR report key: 2900358 · Received January 7, 2013

    Report

    Report Number
    1823260-2013-00132
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 11, 2012
    Report Date
    February 18, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K113137
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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, COMPARED TO A PROFESSIONAL DEVICE, WITHIN 10 MINUTES: 356 MG/DL (NANO) AND 127 MG/DL (EMT METER). 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
    6300 ACCU-CHEK ® SMARTVIEW TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 470786

    Patients

    Seq Age Sex Outcome Treatment
    1 048 YR LANTUS| METFORMIN| LISINOPRIL 1X NIGHTLY