BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 2945515 · Received February 6, 2013

    Report

    Report Number
    1823260-2013-00696
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 9, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: 30.6 MMOL/L (11:55 AM), 12.2 MMOL/L (12:03 PM), 22 MMOL/L (12:07 PM), AND 9.6 MMOL/L (12:15 PM). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50791 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278181

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR JANUVIA| LEVEMIR| HUMALOG| EZETROL| PROMETRIUM| METFORMIN| AVAPRO| ESTRACE| "PROBESOPROLOL"| PLAVIX| LIPITOR