BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 2991282 · Received March 6, 2013

    Report

    Report Number
    1823260-2013-01341
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 IS FOR THE MOBILE SYSTEM. REFERENCE MEDWATCH WITH (B)(6) FOR THE PERFORMA SYSTEM.

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON TWO DIFFERENT METERS WITHIN 10 MINUTES: 318 MG/DL (MOBILE) AND 100 MG/DL (PERFORMA). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95368 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278157

    Patients

    Seq Age Sex Outcome Treatment
    1 010 YR