BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 5051811 · Received September 2, 2015

    Report

    Report Number
    2027969-2015-00644
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 3, 2015
    Report Date
    August 6, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DISCREPANT LOW RESULTS WERE OBSERVED FROM ANY DEVICES TESTED WITH CM CALIBRATOR I; A TNI CV OF 8.99% IS WITHIN THE DEVICE PRODUCT INSERT CLAIM. REVIEWED THE MANUFACTURING BATCH RECORDS FOR CARDIAC LOT W59245B. NO ISSUES WITH TNI RECOVERY OBSERVED. THE LOT PASSED ALL FINAL RELEASE SPECIFICATIONS. DUE TO THE COMPARISON OF RESULTS FROM DIFFERENT SAMPLE DRAWS AND DELAYS BETWEEN TEST RESULTS, A MYOCARDIAL INFARCTION (MI) EVENT OCCURRING BETWEEN TRIAGE AND VISTA REFERENCE RESULTS CANNOT BE RULED OUT; CORRELATION CANNOT BE MADE. NO SAMPLE WAS RETURNED. UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCE AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. NO PRODUCT DEFICIENCY WAS ESTABLISHED. LOT PERFORMED AS EXPECTED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME. OTHER PRODUCT CODES FOR THIS PRODUCT ARE: NBC, DDR AND JHX.

    Description of Event or Problem · 1

    CALLER REPORTED A DISCREPANT LOW TROPONIN I (TNI) RESULT WITH TRIAGE CARDIAC PANEL TEST VS. LAB ANALYZER. PATIENT SAMPLE WAS DRAWN AT 11:39AM ON (B)(6) 2015 AT A CARE FACILITY AND RECEIVED A NEGATIVE RESULT FOR TNI USING THE TRIAGE CARDIAC PANEL TEST. PATIENT HAD CHEST PAIN FOR 2 WEEKS AND ASSOCIATED SHORTNESS OF BREATH. BECAUSE OF THESE SYMPTOMS, THE PATIENT WAS SENT TO A LOCAL HOSPITAL. AT THE HOSPITAL, THE PATIENT HAD A TOTAL OF FOUR LAB DRAWS. THE FIRST DRAW AT 12:29PM THAT WAS RUN ON THE HOSPITAL LAB ANALYZER GAVE AN INDETERMINATE RESULT. THE NEXT THREE RESULTS WERE CONSISTENT WITH ACUTE MYOCARDIAL INJURY. CUSTOMER CALLED BACK WITH AN UPDATE: ADMITTING DIAGNOSIS TO THE HOSPITAL WAS ANTERIOR MYOCARDIAC INFARCTION AND STEMI. THIS WEEK, THE PATIENT RECEIVED A HEART CATHETER, HAD 3 STENTS PLACED, AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. THE CALLER DID NOT HAVE ANY ADDITIONAL INFORMATION ON THE PATIENT, BUT STATES HE IS IN GOOD CONDITION CURRENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583134 TRIAGE CARDIAC PANEL 25 TEST CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. 97000HS W59245B

    Patients

    Seq Age Sex Outcome Treatment
    1