BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3800700 · Received May 8, 2014

    Report

    Report Number
    1823260-2014-03319
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE MOBILE SYSTEM WITHIN 10 MINUTES: 260 MG/DL, 213 MG/DL, 131 MG/DL, 246 MG/DL, 155 MG/DL, 202 MG/DL, 166 MG/DL, 204 MG/DL, 168 MG/DL, 253 MG/DL, 211 MG/DL, 252 MG/DL, AND 135 MG/DL. 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
    278792 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278284

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR