BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3013549 · Received March 20, 2013

    Report

    Report Number
    1823260-2013-01703
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 20, 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 GERMANY. 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 278204, EXPIRATION DATE 04/30/2014). REFERENCE MEDWATCH REPORT WITH (B)(6) FOR THE SUSPECT DEVICE USED IN THE AVIVA SYSTEM. REFERENCE MEDWATCH REPORT WITH (B)(6) FOR THE SUSPECT DEVICE USED IN THE COMPACT PLUS SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS WITHIN 10 MINUTES: 339 MG/DL ON THE MOBILE SYSTEM, 170 MG/DL ON THE AVIVA SYSTEM, AND 150 MG/DL ON THE COMPACT PLUS SYSTEM. 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
    116789 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278204

    Patients

    Seq Age Sex Outcome Treatment
    1 073 YR UNK DIALYSIS| BERLINSULIN H