BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 2624061 · Received June 18, 2012

    Report

    Report Number
    2027969-2012-00937
    Event Type
    Injury
    Date Received
    June 18, 2012
    Date of Event
    May 16, 2012
    Report Date
    June 18, 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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PT SAMPLES ARRIVED THAWED, BUT COOL TO THE TOUCH. PRODUCT SUPPORT TESTED RETURNED PT SAMPLES ON RETAINED LOT #K50515 FOR OBSERVATIONS OF TNI RECOVERY. CONCLUSION: DISCREPANT HIGH TNI WAS OBSERVED WITH RETURNED PT SAMPLES. HAMA TESTING DID NOT SHOW ANY HAMA INTERFERENCES FOR SAMPLE 1. RETURNED SAMPLE 1 WAS NEGATIVE FOR TNI ON ACCESS. THERE WERE INSUFFICIENT SAMPLE VOLUME TO CONTINUE INVESTIGATION. DEVICE LOT K50515 WAS PREVIOUSLY TESTED IN-HOUSE ALL RESULTS OF WHOLE BLOOD TESTING RESULTED IN TNI <0.10NG/ML, WITH THE EXCEPTION OF ONE. ONE RESULT GREATER THAN 0.10NG/ML MEET QC RELEASE SPECIFICATIONS. AS OF (B)(6) 2012, THERE ARE A TOTAL OF (B)(6) COMPLAINTS AGAINST LOT K50515. (B)(4) WAS OPENED TO ADDRESS ELEVATED TNI AT LOW END CONCENTRATIONS.

    Description of Event or Problem · 1

    CALLER (POINT-OF-CARE COORDINATOR) REPORTED DISCREPANT TROPONIN (TNI) RESULTS ON THE TRIAGE CARDIAC PANEL COMPARED TO THE LAB. ON (B)(6) 2012, PT PRESENTED TO THE ED AFTER EXPERIENCING CHEST PAIN FOR 2 WEEKS. PT FIRST TESTED ON LOT #K50515 AND RESULTS WERE QUESTIONED. BOTH SAMPLES WERE REPEATED ON DIFFERENT CARDIAC LOT #W51114 AND TNI RESULTS WERE <0.05. PT WAS ADMITTED TO ICU AND TREATED WITH NITROGLYCERIN AND HEPARIN. PT WAS SUBSEQUENTLY TRANSFERRED TO A SISTER FACILITY. LAB TESTING WAS PERFORMED AND GAVE A TNI RESULT OF<0.015 ON THE SIEMENS VISTA. TIME OF TESTING IS NOT KNOWN. CALLER REPORTED THAT THIS PT WAS SENT FOR CATHETERIZATION ON (B)(6) 2012. RESULTS OF ADDITIONAL TESTING AND DISCHARGE DIAGNOSIS ARE NOT KNOWN. TECHNICAL SERVICES QUESTIONED WHY A PT WOULD HAVE BEEN CATHETERIZED IF LAB TNI WAS NEGATIVE. CALLER DID NOT KNOW AND WENT INTO FACILITY ON (B)(6) 2012 AND REPLICATED THE RESULTS BY REPEAT TESTING. THESE WHOLE BLOOD SAMPLES WERE REFRIGERATED UNTIL (B)(6) 2012 WHEN THE PLASMA WAS FROZEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL 25 TEST CARDIAC MARKER PANEL MMI ALERE SAN DIEGO, INC. 97000HS K50515B

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other| R