BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL TEST

    MDR report key: 2004360 · Received February 24, 2011

    Report

    Report Number
    2027969-2011-00401
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PS TESTED RETURNED PLASMA SAMPLES ON TRIAGE AND ACCESS 2. TWO RETURNED PLASMA SAMPLES WITH DRAWN AT 10:47 (B)(6) AND 11:55 (B)(6). QC RETAIN TRIAGE CARDIAC LOT W47737 (EXP 04/05/2011). QC RETAIN TRIAGE CARDIAC LOT W47779 (EXP 06/24/2011). CM CAL H LOT 233283 FROM MFG INVENTORY. CM CAL Z LOT 220190 FROM MFG INVENTORY. TRIAGE METERS WITH GLOBAL STATPAK (GSP) AND TMAS. HAMA ANTIBODY INTERFERENCE TEST: (B)(4). BECKMAN ACCESS2: (B)(4). ACCESS2 MAS CONTROLS. TRIAGE RESULTS: SAMPLE 1: ON W47737 ONLY, ONE REP EACH PRE AND POST HAMA. SAMPLE 2: ON W47737, TWO REPS PRE HAMA AND ONE REP POST HAMA. ON W47779 ONE REP EACH PRE AND POST HAMA. RESULTS OBSERVED WERE INTERNAL QC ERROR E8 (CONTROL ZERO FAILED) PRE AND POST HAMA WITH BOTH SAMPLES. TRACES SHOW TNI SIGNAL AT LEAST 70% LOWER POST HAMA ON BOTH DEVICE LOTS AND WITH BOTH SAMPLES. ACCESS2 TNI RESULTS (NOT ENOUGH SAMPLE TO TEST PRE-HAMA) SAMPLE 1 POST HAMA: 0.01 NG/ML. SAMPLE 2 POST HAMA: 0.00 NG/ML. IN HOUSE TESTING OF THE RETURNED PT SAMPLES ON DEVICE LOTS W47737 AND W47779 REPLICATED THE CUSTOMER'S COMPLAINT OF ERROR CODE E8. THIS ERROR CODE WAS OBSERVED PRE AND POST HAMA TREATMENT WITH EACH SAMPLE ON BOTH DEVICE LOTS. INVESTIGATION CONTINUED: A DECREASE >50% IN THE TNI VALUE WAS OBSERVED POST HAMA TREATMENT WITH EACH SAMPLE. THIS DECREASE IS EVIDENCE OF HAMA INTERFERENCE. THE NSB SPOT ON EACH DEVICE LOT WITH EACH SAMPLE WAS >8 (PRE AND POST HAMA). THIS INCREASE IN NON SPECIFIC BINDING IS ALSO EVIDENCE OF SAMPLE SPECIFIC INTERFERENCE. NON SPECIFIC BINDING OF HETEROPHILIC ANTIBODIES IS KNOWN TO AFFECT ANALYTE RECOVERY. THE CUSTOMER WAS INSTRUCTED NOT TO ACCEPT VALUES FROM TRIAGE DEVICES THAT RESULT IN AN ERROR CODE. IN HOUSE TESTING OF POSITIVE AND NEGATIVE CONTROL SAMPLES SHOWED THE DEVICE LOTS TO BE FUNCTIONING WITHIN MFR RELEASE SPECIFICATIONS. THE ERROR CODE WAS DUE TO INTERFERENCE FROM HETEROPHILIC ANTIBODIES WITHIN THE PT SAMPLE. NO PRODUCT DEFICIENCY WAS ESTABLISHED; NO CORRECTIVE ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER REPORTED A POTENTIAL FALSE POSITIVE TROPONIN I (TNI) RESULT ON TRIAGE CARDIAC PANEL VS. STRATUS ANALYZER. ON (B)(6) 2011 AT 11:30 AM, A FEMALE PT HAD A TROPONIN I RUN (NO OTHER ENZYME VALUES AVAILABLE) WHICH GAVE A POSITIVE RESULT. PT WAS COMPLAINING OF CHEST PRESSURE AFTER FALLING DOWN STAIRS. INITIAL IMPRESSION WAS THE PAIN WAS MOST LIKELY MUSCULOSKELETAL DUE TO THE FALL. DOCTOR TO FOLLOW UP WITH STRESS TEST TO RULE OUT ISCHEMIC HEART DISEASE. PT WAS SENT TO AREA HOSPITAL'S ED FOR FOLLOW UP. BLOOD WAS DRAWN IN THE ED AND RUN ON THEIR STRATUS ANALYZER WITH NEGATIVE RESULTS. PT SAMPLE WAS ORIGINALLY RUN ON A DIFFERENT LOT OF TRIAGE DEVICE (W47779B) BUT GOT INTERNAL QC OUT OF RANGE (E8) TWICE SO TECH RAN SAMPLE ON LOT W47737B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL TEST CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97000HS W47737B

    Patients

    Seq Age Sex Outcome Treatment
    1