BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 2904909 · Received January 9, 2013

    Report

    Report Number
    1823260-2013-00198
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 30, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 STATED THAT PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF 8.8 MMOL/L AND 4.7 MMOL/L, WITHIN 1 MINUTE, WHEN TESTING ON THE ACCU-CHEK MOBILE SYSTEM. NO ADVERSE EVENT WAS REPORTED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12428 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278183

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR