BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 2935609 · Received January 30, 2013

    Report

    Report Number
    1823260-2013-00534
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 28, 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
    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 THE MOBILE SYSTEM (LOT NUMBER 278153, EXPIRATION DATE 10/31/2013). (B)(6).

    Description of Event or Problem · 1

    CUSTOMER RECEIVED RESULTS OF 17.5 MMOL/L, 7.7 MMOL/L, 14.8 MMOL/L, 10.3 MMOL/L AND 15.6 MMOL/L ON THE MOBILE SYSTEM. A RESULT OF 7.0 MMOL/L WAS OBTAINED ON THE COMPACT PLUS SYSTEM. ALL RESULTS WERE OBTAINED WITHIN 10 MINUTES. 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
    40984 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278153

    Patients

    Seq Age Sex Outcome Treatment
    1 059 YR