BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIO PROFILER PANEL

    MDR report key: 2658828 · Received July 12, 2012

    Report

    Report Number
    2027969-2012-01063
    Event Type
    Injury
    Date Received
    July 12, 2012
    Date of Event
    May 29, 2012
    Report Date
    July 12, 2012
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    MMI
    PMA / PMN Number
    030286
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT'S SAMPLE COLLECTED ON (B)(6) 2012, WHICH GAVE A NEGATIVE TNI RESULT WAS RETURNED FOR INVESTIGATION. PRODUCT SUPPORT TESTED RETURNED SAMPLE AND 10 "NORMAL" (APPARENTLY HEALTHY) WHOLE BLOOD EDTA DONORS ON RETAINED LOTS K50690 AND W50654 FOR OBSERVATIONS OF TNI RECOVERY. PRODUCT SUPPORT HAD ADD'L RETENTION INVENTORY OF LOT 250654 AND CONDUCTED FURTHER TESTING ON THIS LOT. CONCLUSION: NO DISCREPANT OR CORRELATION ISSUES WERE OBSERVED WITH WHOLE BLOOD DONORS OR RETURNED PT SAMPLE DURING IN-HOUSE TESTING WITH RETAINED LOTS K50690 AND W50654. TESTING OF BOTH LOTS ON TRIAGE METER GAVE ELEVATED TNI RESULTS, WHICH WERE VERIFIED ON ACCESS. CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING INVESTIGATION. F/U WITH CUSTOMER REVEALED THAT CUSTOMER BELIEVES THAT THE SECOND TRIAGE TNI RESULT OF <0.05 WAS THE FALSE RESULT. THERE WAS NO CORONARY SPASM DURING ANGIOGRAM AND THIS WOULD HAVE BEEN SEEN. ACCORDING TO CUSTOMER, PT MIGHT HAVE HAD A HEALED PLAQUE RUPTURE WITH A TRANSIENT CORONARY THROMBUS, A MYOCARDITIS. LAB TNI WAS 60 ON THE SAME SAMPLE AS THE NEGATIVE TNI. AS OF (B)(6) 2012, THIS IS THE ONLY COMPLAINT AGAINST LOTS K56090 AND W50654. COMPLAINT ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED DISCREPANT TROPONIN (TNI) RESULTS ON THE TRIAGE CARDIO PROFILER PANEL. A (B)(6) FEMALE PT PRESENTED AT 10:00 HOURS ON (B)(6) 2012, COMPLAINING OF A MILD PAIN IN THE MIDDLE OF HER BACK. AT 13:15 HOURS, CENTRAL CHEST PAIN WAS RADIATING FROM THE BACK ASSOCIATED WITH NAUSEA, SWEATING, CLAMMINESS AND PINS AND NEEDLES DOWN THE RIGHT ARM. RESULTS AS FOLLOWS: BLOOD DRAW AT 22:05 HOURS ON (B)(6) 2012, LOT W50654: TNI = 0.18; CK-MB = 2.1; MYO = 31.4, TREATED AS ACS. PT SENT TO CATHETER LAB ON (B)(6) 2012 AND CORONARIES WERE NORMAL. EDTA SAMPLE WAS TAKEN ON (B)(6) 2012 AT 15:50 HOURS, LAB TNI = 652, LOT K50690: TNI = <0.05; CK-MB = 1.7; MYO = 30.8. EDTA SAMPLE SENT TO LAB FOR ANALYSIS. RESULT = 500. CARDIOLOGIST TREATED PT AS A NON ST ELEVATED MI (NSTEMI) REGARDLESS OF RESULTS ON TRIAGE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIO PROFILER PANEL CARDIAC MARKER PANEL MMI ALERE SAN DIEGO, INC 97100CP K50690

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other