BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT,TRIAGE, CARDIAC TNI / CKMB

    MDR report key: 4962080 · Received August 3, 2015

    Report

    Report Number
    2027969-2015-00561
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    May 19, 2015
    Report Date
    July 6, 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

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    CORRECTION: PATIENT WAS NOT SENT TO CATH LAB. ADDITIONAL INFORMATION: PATIENT ORIGINALLY PRESENTED TO HOSPITAL WITH SWEATING, HOT FLASHES, ABNORMAL EKG. HISTORY OF PRIOR MI.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION UPDATE: PRODUCT SUPPORT TESTED CARDIAC LOT W59460 WITH CALIBRATOR H SAMPLE; CV RESULTS WERE WITHIN THE PACKAGE INSERT CLAIM. THE PRODUCT PERFORMED AS EXPECTED. THE CUSTOMER'S COMPLAINT FOR DISCREPANT LOW TNI WAS NOT REPLICATED. CUSTOMER DID NOT RETURN SAMPLE; UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCE AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. BATCH RECORD REVIEW FOUND NO RELEVANT NCS OR TIFS. THIS LOT PASSED ALL SPECIFICATIONS FOR FINAL LOT RELEASE. THE ROOT CAUSE FOR THE DISCREPANT LOW TNI COMPLAINT COULD NOT BE DETERMINED. NO PRODUCT DEFICIENCY WAS ESTABLISHED. THIS PRODUCT PASSED ALL SPECIFICATIONS FOR FINAL LOT RELEASE.

    Description of Event or Problem · 1

    REPORT CALLER ALLEGING DISCREPANT FN TNL VS. BECKMAN ACCESS. (B)(6) FEMALE, MOST LIKELY PRESENTED WITH CHEST PAIN. PATIENT SENT TO CATH LAB BASED ON LAB RESULTS PLUS EKG AND OTHER SUPPORTIVE TEST RESULTS. PATIENT DISCHARGED (B)(6) 2015 TO HOME HEALTH. NO ADVERSE EVENTS REPORTED RELATED TO THE TRIAGE RESULT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505278 KIT,TRIAGE, CARDIAC TNI / CKMB CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97022HS W59460RB

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR