BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    MDR report key: 4953356 · Received July 30, 2015

    Report

    Report Number
    3011393376-2015-02221
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 22, 2015
    Report Date
    September 28, 2015
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LFR
    PMA / PMN Number
    K113137
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 RESULTS OF 266 MG/DL AND 383 MG/DL ON ONE NANO METER AND A RESULT OF 104 MG/DL ON A SECOND NANO METER WITHIN 1 MINUTE. THE SAME VIAL OF TEST STRIPS WAS USED WITH EACH METER. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. THE ALLEGED PRODUCT WAS REPLACED AND REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495980 ACCU-CHEK ® SMARTVIEW TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. NA 473913

    Patients

    Seq Age Sex Outcome Treatment
    1 013 YR ASMANEX| ZYRTEC| LANTUS| NOVOLOG