BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 2861989 · Received December 7, 2012

    Report

    Report Number
    1823260-2012-06166
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 9, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. WILL NOT BE RETURNED TO MANUFACTURER

    Description of Event or Problem · 1

    CUSTOMER RECEIVED THE FOLLOWING APPROXIMATE RESULTS ON THE MOBILE SYSTEM WITHIN 10 MINUTES: 24 OR 25 MMOL/L AND 7 OR 8 MMOL/L. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE; HOWEVER, CUSTOMER NO LONGER HAS THE TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278179

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR GLARGINE - AT NIGHT| NOVORAPID