BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB 25 TEST KIT

    MDR report key: 1459070 · Received June 25, 2009

    Report

    Report Number
    2027969-2009-00496
    Event Type
    Malfunction
    Date Received
    June 25, 2009
    Date of Event
    June 2, 2009
    Report Date
    June 25, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    NBC
    PMA / PMN Number
    042723
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINS FROM DEVICE LOT W44978 WERE TESTED USING IN-HOUSE CALIBRATOR (CAL H). RESULTS ARE AS FOLLOW: NO ERROR CODES OR STANDARD OUTLIERS WERE OBSERVED. PRODUCT SUPPORT OBSERVED ALL DATA POINTS TO BE WITHIN THE MANUFACTURING 1SD RANGE. NO LOW OR HIGH VALUES WERE OBSERVED. COMPLAINT NOT CONFIRMED. NO DISCREPANT RESULTS WERE OBSERVED. THE CUSTOMER DID NOT RETURN ANY SAMPLE FOR THIS COMPLAINT. PRODUCT SUPPORT (PS) WAS UNABLE TO VERIFY THE CUSTOMER'S COMPLAINT. PS COULD NOT RULE OUT ANY SAMPLE SPECIFIC OR ENVIRONMENTAL FACTOR THAT MAY AFFECT ANALYTE RECOVERY. PS COULD NOT CONFIRM THE CLIENT'S OBSERVATION WITHOUT RETURN OF PATIENT SAMPLE. RETAIN TESTING OF THE DEVICE LOT AGAINST INTERNAL PLASMA CONTROLS SHOWED BNP RESULTS WITH NO 2SD OUTLIERS. RECOVERY WAS 95% WITH A %CV OF 4.7. A REVIEW OF MANUFACTURING (MFG) RELEASED DATA FOR THE DEVICE LOT SHOWED RESULTS WITHIN MFG SPECIFICATIONS. PRODUCT DEFICIENCY WAS NOT ESTABLISHED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTING CUSTOMER WITH DISCREPANT BNP RESULTS ON TRIAGE PROFILER SOB 25 TEST KIT. BNP RUN TODAY GAVE 202 ON TRIAGE SOB. SAMPLE SENT TO LAB, UNKNOWN METHOD RUN WITH BNP RESULT OF 4100. RERUN OF SAME SAMPLE IN ED ON DIFFERENT TRIAGE METER RESULTED IN BNP OF 2100, ON ORIGINAL METER BNP WAS 4000. NO INFORMATION ON PATIENT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE PROFILER SOB 25 TEST KIT CARDIAC MARKER TEST NBC BIOSITE INCORPORATED 97300 W44978

    Patients

    Seq Age Sex Outcome Treatment
    1 NI