BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1895016 · Received November 10, 2010

    Report

    Report Number
    1823260-2010-06676
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 28, 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
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE BENZODIAZEPINES PLUS-ONLINE VERSION (BENZ) RESULTS FOR ONE PATIENT. A URINE SAMPLE FROM THE PATIENT IN (B)(6) 2010 GENERATED A NEGATIVE RESULT. (THE SPECIFIC VALUE AND DATE OF TESTING WERE NOT PROVIDED). THIS SAMPLE WAS NOT REPEATED OR SENT FOR CONFIRMATION TESTING. SINCE THE PATIENT HAD BEEN PREVIOUSLY TESTED POSITIVE FOR BENZ, THE PATIENT WAS REDRAWN (B)(6) 2010 AND THE BENZ RESULT WAS -169 NG/ML. THIS BENZ VALUE WAS REPORTED OUTSIDE THE LABORATORY AS NEGATIVE. THE (B)(6) 2010 SAMPLE WAS SENT OUT FOR CONFIRMATION TESTING. CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2010 AND GENERATED A POSITIVE LORAZEPAM (BENZ) RESULT OF >1000 NG/ML. THE CUSTOMER INQUIRED WHETHER THE PATIENT'S MEDICATIONS (CARISOPRODOL, SOMA, SOPRADAL, VANADOM AND "ADAVAN" (ATIVAN)) COULD BE INTERFERING WITH THE ASSAY. THE PHYSICIAN HAD ADDED CARISOPRODOL IN (B)(6) 2010 BUT HAD NOT CHANGED THE ADAVAN. THE PATIENT WAS NOT ADVERSELY AFFECTED DUE TO THIS EVENT. THE BENZ REAGENT LOT NUMBER WAS 15628600. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A SPECIFIC CAUSE. HE PERFORMED CHECKS OF THE MEASUREMENT SYSTEM INCLUDING QUALITY CONTROL. ALL CHECKS AND TESTS WERE ACCEPTABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES: 70 MG/DL, 40 MG/DL, AND 0 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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 551254

    Patients

    Seq Age Sex Outcome Treatment
    1