BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL

    MDR report key: 4669600 · Received April 8, 2015

    Report

    Report Number
    2027969-2015-00254
    Event Type
    Malfunction
    Date Received
    April 8, 2015
    Date of Event
    March 16, 2015
    Report Date
    March 18, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRO CODES: DDR, JHX, MMI. INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: THE DEVICE DID NOT RETURN FOR EVALUATION. THE CUSTOMER'S COMPLAINT OF DISCREPANT TROPONIN WAS NOT REPLICATED WITH IN-HOUSE TESTING. LOT W59216 PERFORMED AS EXPECTED. CUSTOMER RAN ONLY ONE TEST WITH THE TRAIGE CARDIAC DEVICE; DID NOT TEST A SECOND TRIAGE DEVICE FOR CONFIRMATION. NO SAMPLE WAS RETURNED; THEREFORE SAMPLE SPECIFIC INTERFERENCE IS UNABLE TO RULED OUT AS A POTENTIAL CAUSE OF THE COMPLAINT. REVIEW OF THE BATCH RECORDS FOUND NO NON-CONFORMANCES. THE CUSTOMER'S COMPLAINT OF DISCREPANT HIGH TNI WAS NOT OBSERVED. THERE IS ONLY ONE COMPLAINT FOR CARDIAC LOT W59216. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AND ALLEGED A POTENTIAL FALSE POSITIVE TRIAGE TROPONIN (TNI) RESULT IN COMPARISON TO A NEGATIVE TNI ON THE VITROS LABORATORY ANALYZER. ON (B)(6) 2015, THE PATIENT PRESENTED TO URGENT CARE FOR CHEST PAIN. AT 15:57, THE TRIAGE TNI WAS 0.10 AND THE VITROS TNI WAS 0.01. THE CUT-OFF FOR TRIAGE WAS 0.05 - 0.4 "CRITICAL" AND > 0.4 "HIGH CRITICAL." THE CUT-OFF FOR THE VITRO WAS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE RESULT WAS NEGATIVE. THE ELECTROCARDIOGRAM (EKG) SHOWED ABNORMAL T-WAVE AND S-T SEGMENT BUT NO SPECIFICS WAS PROVIDED. THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL. THE SECOND TNI WAS PERFORMED AT 21:00 ON THE VITROS ANALYZER AND WAS 0.01. THERE WAS NO TRIAGE TNI PERFORMED ON THE SECOND DRAW. THE CUSTOMER HAS NO ACCESS TO THE PATIENT'S INFORMATION SINCE THE TRANSFER TO (B)(6) HOSPITAL. THERE WAS NO INVASIVE PROCEDURE PERFORMED OR ANY HARM TO THE PATIENT WHILE AT THE URGENT CARE BASED ON THE TRIAGE RESULT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232427 TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97021HS W59216RB

    Patients

    Seq Age Sex Outcome Treatment
    1 TRIAGE METER| VITROS LABORATORY ANALYZER