BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 4791723 · Received May 22, 2015

    Report

    Report Number
    3011393376-2015-00603
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 17, 2015
    Report Date
    July 13, 2015
    Manufacturer
    ROCHE DIABETES CARE, INC.
    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. THIS MEDWATCH REPORT IS FOR THE SUSPECT PRODUCT USED IN SYSTEM 2. (B)(4).

    Description of Event or Problem · 1

    REPORTER STATED THE CUSTOMER RECEIVED THE FOLLOWING RESULTS ON 2 DIFFERENT METERS WITHIN 2 MINUTES: 284 MG/DL (MOBILE SYSTEM 1) AND 125 MG/DL (MOBILE SYSTEM 2). THE SAME LOT NUMBER OF TEST STRIPS WAS USED IN EACH METER. NO ADVERSE EVENT DUE TO THE DEVICE REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335496 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. NA 278329

    Patients

    Seq Age Sex Outcome Treatment
    1 075 YR