BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 1950695 · Received January 6, 2011

    Report

    Report Number
    1823260-2011-00065
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 18, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). CUSTOMER WAS CONTACTED BY RDC (B)(4) TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ALLEGED DISCREPANT RESULTS. CUSTOMER DENIED EVER OBTAINING THE ALLEGED RESULTS.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 3.7 MMOL/L AND 5.9 MMOL/L WITHIN 10 MINUTES ON THE MOBILE 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
    1 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 277065

    Patients

    Seq Age Sex Outcome Treatment
    1