BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    MDR report key: 3812554 · Received May 15, 2014

    Report

    Report Number
    1823260-2014-03440
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 16, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K113137
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT STRIPS WERE ALL CONSUMED BY THE CUSTOMER PRIOR TO CONTACTING THE MANUFACTURER. DEVICE IS NOT AVAILABLE FOR RETURN. IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 95 MG/DL AND 214 MG/DL WITHIN 10 MINUTES ON THE NANO SMART VIEW SYSTEM. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE BUT CUSTOMER INDICATED ALL STRIPS FROM STRIP VIAL IN USE AT TIME OF THE EVENT HAD BEEN CONSUMED PRIOR TO CUSTOMER CONTACTING MANUFACTURER. PRODUCT REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290447 ACCU-CHEK ® SMARTVIEW TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 048 YR METFORMIN| ALLERGY PILL| BENADRYL| POTASSIUM| OMEPRAZOLE| DIOVAN| AMLODIPINE BESYLATE| DIPHENHYDRAMINE| LORATADINE