BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 4770956 · Received May 14, 2015

    Report

    Report Number
    3011393376-2015-00290
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    April 21, 2015
    Report Date
    August 3, 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
    AS
    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 RESULTS OF 11.4 MMOL/L, "HI" (>33.3 MMOL/L), "HI" (>33.3 MMOL/L), AND 26.5 MMOL/L WITHIN 2 MINUTES ON THE MOBILE SYSTEM. CUSTOMER REPORTED HE "ROLLS" HIS FINGER ON THE TEST CASSETTE TO APPLY BLOOD, AND HE WAS ADVISED OF CORRECT TECHNIQUE. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316180 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. NA 278316

    Patients

    Seq Age Sex Outcome Treatment
    1 074 YR LANTUS INSULIN| APIDRA INSULIN