BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3965096 · Received July 29, 2014

    Report

    Report Number
    1823260-2014-05658
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 29, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 RECEIVED A RESULT OF 260 MG/DL ON THE MOBILE SYSTEM WHILE A COMPARISON LAB RETURNED AS 80 MG/DL WITHIN 10 MINUTES. ON A DIFFERENT OCCASION THE CUSTOMER RECEIVED RESULTS OF 54 MG/DL AND 149 MG/DL ON THE MOBILE SYSTEM 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
    440906 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278300

    Patients

    Seq Age Sex Outcome Treatment
    1