BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MOBILE TEST STRIPS

    MDR report key: 2183284 · Received July 28, 2011

    Report

    Report Number
    1823260-2011-04072
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE MOBILE SYSTEM WITHIN 10 MINUTES: 26.1 MMOL/L AND 6.9 MMOL/L; 22.8 MMOL/L AND 3.3 MMOL/L. THE COMPARISONS WERE PERFORMED ON DIFFERENT DATES. CUSTOMER REPORTED LOW BLOOD GLUCOSE SYMPTOMS DURING THE SECOND COMPARISON. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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 277072

    Patients

    Seq Age Sex Outcome Treatment
    1 010 YR LANTUS| NOVORAPID