BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3162599 · Received June 11, 2013

    Report

    Report Number
    1823260-2013-03512
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    August 12, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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

    REPORTER ALLEGED THE CUSTOMER HAD HYPOGLYCEMIC SYMPTOMS OF "BLURRED VISION AND FAINTED." IT IS UNCLEAR IF THE CUSTOMER FAINTED OR FELT FAINT. IT IS NOTED CUSTOMER TESTED ON HER MOBILE DEVICE AT THIS TIME AND RECEIVED THE FOLLOWING RESULTS: 72 MG/DL AT 3:44 PM, 60 MG/DL AT 3:47 PM. THE CUSTOMER TESTED ON A COMPETITOR DEVICE AT 3:47 PM AND RECEIVED A RESULT OF 40 MG/DL. THE CUSTOMER'S WORK COLLEAGUE PROVIDED HER WITH "SOME SUGAR" AND THE CUSTOMER RECOVERED. 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
    262915 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278201

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR UNSPECIFIED INSULIN