BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2110699 · Received June 1, 2011

    Report

    Report Number
    1823260-2011-02920
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 9, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. OTHER: WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED 21 MG/DL ON AN UNSPECIFIED INFORM METER AT 10:21. AT 10:23 PATIENT WAS TREATED WITH D50% BASED ON THIS METER RESULT. AT 10:57 PATIENT TESTED LO (LESS THEN 9 MG/DL) ON THE SAME SYSTEM; AT 11:00 PATIENT TESTED 23 MG/DL ON THE ALLEGED INFORM SYSTEM WHILE USING COMFORT CURVE TEST STRIPS. A LAB VALUE WAS DRAWN AT 11:58 AND RESULT RETURNED AS 245 MG/DL. NO FURTHER ACTION WAS TAKEN. CALLER STATES THE PATIENT'S EXTREMITIES WERE BLACKENED DUE TO BLOOD FLOW ISSUES. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER CALLER NO LONGER HAS THE TEST STRIPS; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551402

    Patients

    Seq Age Sex Outcome Treatment
    1