BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    MDR report key: 3103124 · Received May 9, 2013

    Report

    Report Number
    1823260-2013-02856
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 2, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K113137
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: 1, 258 MG/DL AND 111 MG/DL 2. 244 MG/DL AND 110 MG/DL 3. 226 MG/DL AND 105 MG/DL SETS OF READINGS WERE TAKEN ON DIFFERENT DAYS. 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
    204439 ACCU-CHEK ® SMARTVIEW TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 471173

    Patients

    Seq Age Sex Outcome Treatment
    1 080 YR LASIX| DIGOXIN| OCUVITE| PACEMAKER| FEXOFENADINE| DEFIBRILLATOR| CARDIZEM| LOSARTAN| SOTALOL| FOLBIC| JANTOVEN| LIPITOR| LOPID| NEXIUM| PROSTHETIC KNEE| PROSTHETIC HEART VALVE| ASPIRIN| FLONASE| LANTUS