BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3854129 · Received June 6, 2014

    Report

    Report Number
    1823260-2014-04140
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 20, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER AND EXPIRATION DATE UNKNOWN). (B)(4).

    Description of Event or Problem · 1

    CUSTOMER RECEIVED RESULTS OF 20.8 MMOL/L, HI (GREATER THAN 33.3 MMOL/L), HI, AND HI ON MOBILE SYSTEM 1, AND RESULTS OF 2.8 MMOL/L AND 2.9 MMOL/L ON MOBILE SYSTEM 2 WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331157 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 015 YR "MY LIFE" INSULIN PUMP| NOVORAPID