BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2082654 · Received May 10, 2011

    Report

    Report Number
    1823260-2011-02471
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 7, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. FACILITY FAXES OF PATIENT MEDICAL RECORD AND BMP ARE ATTACHED.

    Description of Event or Problem · 1

    INFORM USER FACILITY REPORTED PATIENT FINGER STICK BLOOD GLUCOSE RESULT OF 30 MG/DL AT 16:35. PATIENT WAS GIVEN 1 AMP OF D50 AT 16:40. A LAB SAMPLE DRAWN AT 16:43 WAS RESULTED AS 291 MG/DL. INFORM FINGER STICK RESULT AT 17:04 WAS 110 MG/DL, 299 MG/DL AT 17:30. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS.

    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 551379

    Patients

    Seq Age Sex Outcome Treatment
    1 049 YR PLEASE SEE ATTACHED MEDICAL RECORD