BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SENSOR COMFORT TEST STRIPS

    MDR report key: 2152139 · Received July 7, 2011

    Report

    Report Number
    1823260-2011-03645
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 30, 2011
    Report Date
    November 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 A SENSOR RESULT OF 120 MG/DL, PROFESSIONAL SYSTEM RESULT OF 74 MG/DL WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.

    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 571516

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR