BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SENSOR COMFORT TEST STRIPS

    MDR report key: 1971494 · Received January 27, 2011

    Report

    Report Number
    1823260-2011-00443
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 9, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED SENSOR BLOOD GLUCOSE RESULT OF 435 MG/DL, PROFESSIONAL METER RESULT 125 MG/DL WITHIN 10 MINUTES. REPORTED NO ADVERSE EVEN. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 046 YR