BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3833549 · Received May 27, 2014

    Report

    Report Number
    1823260-2014-03730
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 2, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 1 (LOT NUMBER 278271, EXPIRATION DATE 03/31/2015). (B)(4).

    Description of Event or Problem · 1

    CUSTOMER RECEIVED RESULTS OF 16 MMOL/L, 13 MMOL/L, AND 14 MMOL/L ON MOBILE SYSTEM 1, AND A RESULT OF 3.3 MMOL/L ON MOBILE SYSTEM 2 WITHIN 10 MINUTES. THE CUSTOMER REPORTED LOW BLOOD GLUCOSE SYMPTOMS WITH THESE RESULTS; HE CONSUMED FOOD. LATER THAT DAY THE CUSTOMER RECEIVED RESULTS BETWEEN 13 MMOL/L AND 16 MMOL/L ON MOBILE SYSTEM 1, AND A RESULT OF 5 MMOL/L ON MOBILE SYSTEM 2 WITHIN 10 MINUTES. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310262 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278271

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR