BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PROFILER KIT

    MDR report key: 2222387 · Received July 15, 2011

    Report

    Report Number
    2027969-2011-01566
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SUPPORT OBSERVATIONS FOR TNI RECOVERY FOLLOW: SAMPLE SPECIFIC INTERFERENCE WAS OBSERVED WITH THE 2 RETURNED PT SAMPLES (PRE AND POST HAMA). NEGATIVE AND POSITIVE CONTROLS FUNCTIONED WITHIN MFG RELEASE SPECS. ERROR CODES WERE OBSERVED WITH BOTH OF THE RETURNED PT SAMPLES. PT SAMPLE 1 TNI VALUE WAS OBSERVED AT 11.9 PRE HAMA AND 5.0 POST HAMA (THE INTEGRAL VALUE WAS 52.6 AND 22.1, RESPECTIVELY). A DECREASE >50% IN TNI AND INTEGRAL VALUE IS EVIDENCE OF INTERFERENCE FROM A HETEROPHILIC ANTIBODY THAT IS AFFECTING ANALYTE RECOVERY. THIS INTERFERENCE IS LIKELY THE CAUSE OF THE ERROR CODES AND INCORRECT ANALYTE RECOVERY ON THE TRIAGE DEVICES. PT SAMPLE 2 TNI VALUE WAS OBSERVED AT 5.0 PRE HAMA AND 4.8 POST HAMA. PRODUCT SUPPORT COULD NOT RULE OUT SAMPLES SPECIFIC INTERFERENCE AS A CAUSE OF INTERFERENCE WITH ANALYTE RECOVERY. ALL DATA POINTS WITH CAL Z WERE BELOW THE MFG CUT OFF. ONE DATA POINT WITH CAL H WAS ABOVE THE MFG 2SD RANGE WITH A % RECOVERY OF 91% (WITHIN THE MFG FINAL RELEASE SPECS). BOTH PT SAMPLES RECEIVED ERROR CODES DURING TESTING ON BOTH PRE AND POST HAMA TREATMENT. SAMPLE 1 HAD A <50% DECREASE IN TNI VALUE AFTER HAMA TREATMENT (PRE 11.9 NG/ML/ POST 5.0 NG/ML). THIS EVIDENCE OF HETEROPHILIC ANTIBODY (HAMA) INTERFERENCE THAT IS KNOWN TO AFFECT ANALYTE RECOVERY. SAMPLE 2 DID NOT SHOW AN EVIDENCE OF HAMA INTERFERENCE BUT BOTH SAMPLES HAD ELEVATED NSB VALUES WHICH INDICATES SAMPLE SPECIFIC INTERFERENCE THAT IS KNOWN TO AFFECT ANALYTE RECOVERY. PRODUCT SUPPORT ALSO TESTED THE PT SAMPLES ON ACCESS II. TNI ON BOTH SAMPLES WAS 0.00 NG/ML. TESTING WITH CAL Z AND H SHOWED NO ISSUES WITH DEVICE LOT PERFORMANCE. NO FALSE POSITIVE RESULTS OR HIGH BIAS WAS OBSERVED WITH EITHER CONTROL SAMPLE. ELEVATED TNI RESULTS WERE CAUSED BY SAMPLE SPECIFIC INTERFERENCE THAT IS KNOWN TO AFFECT ANALYTE RECOVERY. (B)(4). NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES FALSE POSITIVE TROPONIN I (TNI) RESULT WITH METER: DATE: (B)(6) 2011, PT TESTED ON TRIAGE. CK-MB 25.9; TNI 4.84; MYO >500. AT SAME FACILITY, PLASMA THEN RAN ON BECKMANN COULTER ACCESS AND SIEMENS CENTAUR: BC ACCESS: TNI <0.01; CENTAUR: TNI <0.01. CUSTOMER SAID PT WAS INITIALLY SEEN AT END OF (B)(6) ALSO FOR CHEST PAIN, DISCHARGED AND RULED RELATED TO ANXIETY. CUSTOMER ADDED PT HAD ADMITTED TO BE GOING THROUGH MANY PERSONAL PROBLEMS THIS SECOND VISIT, ON (B)(6), PT CAME IN WITH SAME COMPLAINT, CHEST PAIN. PHYSICIAN RA EKG, NON-SPECIFIC ST-T WAVE CHANGES, PHYSICIAN THEN ORDERED HEART CAT TEST, ALL NORMAL. PT THEN DISCHARGED, CONCLUDED CAUSED BY ANXIETY. PT'S COMPLETE MEDICAL HISTORY UNK BY CALLER. CUSTOMER SUSPECTS SAMPLE SPECIFIC INTERFERENCE, TO SEND FROZEN PLASMA FOR TESTING. SAMPLE IS REMAINDER RAN ON TRIAGE, SPUN DOWN. NO ADD'L SAMPLES LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PROFILER KIT CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. 97100CP W48406B

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR