BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2162379 · Received July 14, 2011

    Report

    Report Number
    1823260-2011-03742
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 27, 2011
    Report Date
    September 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1. REFERENCE MEDWATCH REPORT WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    Description of Event or Problem · 1

    REPORTER ALLEGED THE PATIENT RECEIVED A RESULT OF 158 MG/DL ON INFORM SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 25 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.

    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 551462

    Patients

    Seq Age Sex Outcome Treatment
    1