BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3880122 · Received June 18, 2014

    Report

    Report Number
    1823260-2014-04429
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 25, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. NO EVALUATION IS POSSIBLE BECAUSE THE PATIENT RETURNED AN EMPTY VIAL OF STRIPS. EMPTY VIAL OF TEST STRIPS WAS RETURNED.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED A RESULT OF 17.2 MMOL/L ON THE MOBILE SYSTEM AND A RESULT OF 4.3 MMOL/L ON AN UNKNOWN ACCU-CHEK SYSTEM WITHIN 10 MINUTES. THE CUSTOMER FELT FAINT WITH THESE RESULTS. HE WAS ABLE TO SELF-TREAT WITH FOOD. 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
    357015 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278288

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR HUMALOG