BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3984577 · Received August 6, 2014

    Report

    Report Number
    1823260-2014-05929
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 14, 2014
    Report Date
    August 6, 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. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2. (B)(4). DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON 2 DIFFERENT METERS WITHIN 10 MINUTES: 344 MG/DL (MOBILE SYSTEM 1) AND 135 MG/DL (MOBILE SYSTEM 2). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT DUE TO THE DEVICE REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459975 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 081 YR FAT METABOLISM MEDICATION| INSULIN| BLOOD PRESSURE MEDICATION