BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3873689 · Received June 16, 2014

    Report

    Report Number
    1823260-2014-04342
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 2, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LOW BLOOD GLUCOSE SYMPTOMS WITH A RESULT OF 6.0 MMOL/L OBTAINED ON THE MOBILE SYSTEM. CUSTOMER'S NON-ROCHE METERS RETURNED AS 3.0 MMOL/L AND 3.6 MMOL/L. TREATMENT INFORMATION WAS NOT PROVIDED. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352358 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278271

    Patients

    Seq Age Sex Outcome Treatment
    1 014 YR OPTIUM METER| ONE TOUCH VERIO METER