BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1904998 · Received November 22, 2010

    Report

    Report Number
    1823260-2010-06932
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 16, 2010
    Report Date
    January 19, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1. (B)(6). WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    REPORTER ALLEGED THE PATIENT RECEIVED A RESULT OF 319 MG/DL ON INFORM SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 148 MG/DL ON INFORM SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT. REPORTER STATED THAT THEY NO LONGER HAVE THE STRIPS, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 551299

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN - TYPE UNKNOWN