BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1852953 · Received October 5, 2010

    Report

    Report Number
    1823260-2010-05885
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 20, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE ADVANTAGE SYSTEM. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 74 MG/DL (AVIVA) AND 153 MG/DL (ADVANTAGE). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS ERRONEOUS HIGH ACCUTNI RESULT ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF FOR ONE PATIENT GENERATED BY UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE SAMPLE WAS REPEATED ON THE SAME AND AN ALTERNATE UNIT AND LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE WERE OBTAINED. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE LFR ROCHE DIAGNOSTICS 551355

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR METFORMIN| GLARGINE| GLIPIZIDE