BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT,TRIAGE, CARDIAC TNI

    MDR report key: 4902425 · Received July 9, 2015

    Report

    Report Number
    2027969-2015-00498
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 22, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODES: DDR, JHX, MMI. INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: THERE WAS NO DISCREPANT LOW RESULTS, DEVICE ISSUES OR ERROR CODES OBSERVED DURING TESTING. DATA RESULTS FROM ALL DEVICES TESTED WERE WITHIN MANUFACTURING FINAL RELEASE SPECIFICATIONS. MANUFACTURING BATCH RECORDS FOR CARDIAC LOT W59182RB WERE REVIEWED AND THERE WERE NO ISSUES WITH TNI RECOVERY OBSERVED AND THE LOT PASSED ALL FINAL RELEASE SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED, THEREFORE SAMPLE SPECIFIC INTERFERENCE AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS COULD NOT BE RULED OUT. THERE WAS NO PRODUCT DEFICIENCY ESTABLISHED WITH THE TRIAGE CARDIAC DEVICE LOT.

    Description of Event or Problem · 1

    CUSTOMER WAS RUNNING PATIENT COMPARISONS FROM THEIR ACCESS ANALYZER TO THEIR TRIAGE MONITOR WHICH IS USED FOR BACK UP. CUSTOMER RAN THESE SAMPLES AS PART OF A CORRELATION STUDY. THERE WAS ONLY 1 PATIENT INVOLVED WHICH REPORTED DISCREPANT LOW TNI RESULTS. THE PATIENT IS A (B)(6) FEMALE THAT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF PNEUMONIA ON (B)(6) 2015. THE FOLLOWING ARE THE REPORTED RESULTS: (B)(6). ALL DRAWS WERE SPLIT FOR ACCESS AND TRIAGE. TRIAGE USED EDTA WHOLE BLOOD. NO EKG INFORMATION AVAILABLE. NO RESULTS ON TRIAGE FOR CKMB, MYO, BNP. CURRENT DIAGNOSIS WAS PNEUMONIA IN THE CHART. THE PATIENT WAS TREATED AS "AMI" PER PHYSICIAN COMMENT. DETAIL OF TREATMENT IS NOT AVAILABLE. NO CLINICAL DECISIONS WERE MADE BASED ON RESULTS ON TRIAGE. NO TREATMENT WAS ORDERED OR WITHHELD BASED ON TNI RESULTS ON TRIAGE. NO DEATH OR HARM OCCURRED. ALL SAMPLES WERE TESTED AS EDTA WHOLE BLOOD FOR TRIAGE, AT ROOM TEMPERATURE. TEST PROCEDURE VERIFIED; ROOM TEMP WAS NORMAL AND NO INTERFERENCE FROM OTHER EQUIPMENT TO TRIAGE NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446671 KIT,TRIAGE, CARDIAC TNI CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97021HS W59182RB

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR ACCESS ANALYZER| TRIAGE MONITOR SN (B)(4)