BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL

    MDR report key: 2082599 · Received April 27, 2011

    Report

    Report Number
    2027969-2011-00939
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    NBC
    PMA / PMN Number
    030286
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SUPPORT TESTED CARDIAC LOTS W48663 AND W49106 ON POSITIVE CONTROL, CALIBRATOR H AND TWO NORMAL WHOLE BLOOD (EDTA) DONOR SAMPLES. OBSERVATIONS WERE MADE FOR CK-MB AND TNI RECOVERY. NO SIGNIFICANT VARIATION WAS OBSERVED BETWEEN DEVICE LOTS WITH ANY SAMPLES. RESULTS FOR W48663: WHOLE BLOOD SAMPLE 2: ONE ERROR CODE WAS OBSERVED; ONE DATA POINT FOR TNI WAS AT 0.07 NG/ML, ALL OTHERS WERE <0.05 NG/ML. CK-MB VALUES RANGED FROM <1.0 TO 2.1 (N=8). WHOLE BLOOD SAMPLE 1: ALL TNI VALUES WERE <0.05 NG/ML (N=3); CK-MB VALUES RANGED FROM 1.1 TO 1.4 (N=3). ALL DATA POINTS FOR TNI AND CK-MB WITH CALIBRATOR H, ON BOTH DEVICE LOTS, WERE WITHIN THE MFG 2SD RANGE, 105% AND 95%, RESPECTIVELY. RESULTS FOR W49106: WHOLE BLOOD SAMPLE 1: ALL DATA POINTS FOR TNI WERE 0.05NG/ML (N=3); ALL DATA POINTS FOR CK-MB WERE <1.0 NG/ML (N=3). WHOLE BLOOD SAMPLE 2: ALL TNI VALUES WERE <0.05NG/ML (N=3); CK-MB VALUES RANGED FROM 1.1 TO 2.1 (N=3). ALL DATA POINTS FOR TNI AND CK-MB WITH CALIBRATOR H WERE WITHIN THE MFG 2SD RANGE, 105% AND 95, RESPECTIVELY. NO SAMPLES WERE RETURNED FOR TESTING. PRODUCT SUPPORT WAS UNABLE TO VERIFY THE CUSTOMER'S RESULT. PRODUCT SUPPORT COULD NOT RULE OUT ANY SAMPLE SPECIFIC OR ENVIRONMENTAL FACTORS THAT MAY HAVE AFFECTED ANALYTE RECOVERY. THE CUSTOMER'S DATA WAS BASED ON LIMITED REPLICATES WITH LIMITED SAMPLES. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WHEN CORRELATING TROPONIN (TNI) VALUES BETWEEN OLD LOT AND NEW LOT ON THE TRIAGE CARDIAC PANEL FOR ONE PT. TEST DEVICES ARE EQUILIBRATED TO ROOM TEMPERATURE FOR 15 TO 30 MINUTES. LAB TEMPERATURE IS COMFORTABLE AND TESTING WAS DONE SIDE BY SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL CARDIAC PANEL MARKER NBC ALERE SAN DIEGO, INC 97000HS W49106

    Patients

    Seq Age Sex Outcome Treatment
    1 NI