BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL

    MDR report key: 1172690 · Received September 20, 2008

    Report

    Report Number
    2027969-2008-00012
    Event Type
    Malfunction
    Date Received
    September 20, 2008
    Date of Event
    June 4, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED FOR LACK OF SPECIMEN. TESTING OF CLINICAL SPECIMENS ON RETAINS REFLECTED GOOD AGREEMENT WITH ACCESS. LOT REVIEW INDICATED NO OBSERVED RECOVERY FAILURES. UNRESOLVED QUESTIONS REGARDING SAMPLE HANDLING BY CUSTOMER. ISSUE NOT CONFIRMED.

    Description of Event or Problem · 1

    DISTRIBUTOR IN A FOREIGN COUNTRY REPORTS THAT AN EVALUATION STUDY WAS CONDUCTED BY A CUSTOMER COMPARING TROPONIN I (TNI) RESULTS RUN ON THE BECKMAN ACCESS 2 (BCI) WITH RESULTS RUN ON THE TRIAGE CARDIAC PANEL. TWELVE SAMPLES SHOW POTENTIALLY FALSE NEG TNI RESULTS ON TRIAGE AS COMPARED WITH BCI. THE CUSTOMER'S DATA SUMMARY SHOWS TWO DIFFERENT CUT-OFF LEVELS FOR EACH PLATFORM. USING A CUT-OFF OF 0.5 ON BCI AND 0.4 ON TRIAGE THERE WERE POTENTIAL FALSE NEGATIVE TNI RESULTS. THE FOLLOWING CLINICAL INFORMATION WAS PROVIDED ON THESE FOUR PATIENTS. IN 2008 6:00 BCI=0.74 TRIAGE=0.23 CKMB<1.0 MYO=54.4, CAOD, CABG. EIGHT ADDITIONAL SAMPLES WERE REPORTED, NO DATA PROVIDED.

    Description of Event or Problem · 2

    DISTRIBUTOR IN A FOREIGN COUNTRY REPORTS THAT AN EVALUATION STUDY WAS CONDUCTED BY A CUSTOMER COMPARING TROPONIN I (TNI) RESULTS RUN ON THE BECKMAN ACCESS 2 (BCI) WITH RESULTS RUN ON THE TRIAGE CARDIAC PANEL. TWELVE SAMPLES SHOW POTENTIALLY FALSE NEG TNI RESULTS ON TRIAGE AS COMPARED WITH BCI. THE CUSTOMER'S DATA SUMMARY SHOWS TWO DIFFERENT CUT-OFF LEVELS FOR EACH PLATFORM. USING A CUT-OFF OF 0.5 ON BCI AND 0.4 ON TRIAGE THERE WERE POTENTIAL FALSE NEGATIVE TNI RESULTS. THE FOLLOWING CLINICAL INFORMATION WAS PROVIDED ON THESE FOUR PATIENTS. IN 2008 6:48 BCI=0.88 TRIAGE<0.05 CKMB=1.1 MYO=68 NON-ST ELEVATION MI, DEATH. EIGHT ADDITIONAL SAMPLES WERE REPORTED, NO DATA PROVIDED.

    Description of Event or Problem · 3

    DISTRIBUTOR IN FOREIGN COUNTRY REPORTS THAT AN EVALUATION STUDY WAS CONDUCTED BY A CUSTOMER COMPARING TROPONIN I (TNI) RESULTS RUN ON THE BECKMAN ACCESS 2 (BCI) WITH RESULTS RUN ON THE TRIAGE CARDIAC PANEL. TWELVE SAMPLES SHOW POTENTIALLY FALSE NEG TNI RESULTS ON TRIAGE AS COMPARED WITH BCI. THE CUSTOMER'S DATA SUMMARY SHOWS TWO DIFFERENT CUT-OFF LEVELS FOR EACH PLATFORM. USING A CUT-OFF OF 0.5 ON BCI AND 0.4 ON TRIAGE THERE WERE POTENTIAL FALSE NEGATIVE TNI RESULTS. THE FOLLOWING CLINICAL INFORMATION WAS PROVIDED ON THESE FOUR PATIENTS. IN 2008 9:07 BCI=0.71 TRIAGE<0.05 CKMB=16.1 MYO>500 PNEUMONIA, PROGRESSIVE MUSCULAR DYSTROPHY, DILATED CARDIOMYOPATHY, CHEST PAIN ORIGIN IS PNEUMONIA. EIGHT ADDITIONAL SAMPLES WERE REPORTED, NO DATA PROVIDED.

    Additional Manufacturer Narrative · 4

    CUSTOMER COMPLAINT COULD NOT BE CONFIRMED FOR LACK OF SPECIMEN. TESTING OF CLINICAL SPECIMENS ON RETAINS REFLECTED GOOD AGREEMENT WITH ACCESS. LOT REVIEW INDICATED NO OBSERVED RECOVERY FAILURES. UNRESOLVED QUESTIONS REGARDING SAMPLE HANDLING BY CUSTOMER. ISSUE NOT CONFIRMED.

    Description of Event or Problem · 4

    DISTRIBUTOR IN FOREIGN COUNTRY REPORTS THAT AN EVALUATION STUDY WAS CONDUCTED BY A CUSTOMER COMPARING TROPONIN I (TNI) RESULTS RUN ON THE BECKMAN ACCESS 2 (BCI) WITH RESULTS RUN ON THE TRIAGE CARDIAC PANEL. TWELVE SAMPLES SHOW POTENTIALLY FALSE NEG TNI RESULTS ON TRIAGE AS COMPARED WITH BCI. THE CUSTOMER'S DATA SUMMARY SHOWS TWO DIFFERENT CUT-OFF LEVELS FOR EACH PLATFORM. USING A CUT-OFF OF 0.5 ON BCI AND 0.4 ON TRIAGE THERE WERE POTENTIAL FALSE NEGATIVE TNI RESULTS. THE FOLLOWING CLINICAL INFORMATION WAS PROVIDED ON THESE FOUR PATIENTS. IN 2008 12:00 BCI=0.57 TRIAGE=0.09 CKMB=2.9, MYO=67.6 CAOD 1VESSEL CAOD-CORONARY ARTERY OBSTRUCTIVE DISEASE. EIGHT ADDITIONAL SAMPLES WERE REPORTED, NO DATA PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL CARDIAC MARKER TEST MMI BIOSITE INCORPORATED 97000HS W42798B

    Patients

    Seq Age Sex Outcome Treatment
    1
    2
    3
    4