BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, TRIAGE, CARDIAC TNI

    MDR report key: 3884154 · Received May 19, 2014

    Report

    Report Number
    2027969-2014-00449
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ELEVATED OR DISCREPANT HIGH TNI RESULTS WERE OBSERVED FROM ANY DEVICES TESTED WITH "NORMAL" (APPARENTLY HEALTHY) WB EDTA DONOR SAMPLES. TESTING RESULTS OF RETURNED PT SAMPLES SHOW THAT SAMPLES CONTAIN HAMA ANTIBODY INTERFERENCE. NO PRODUCT DEFICIENCY WAS ESTABLISHED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER REPORTED POTENTIAL DISCREPANT HIGH TROPONIN I (TNI) RESULTS ON TRIAGE VS. LAB ANALYZER. (B)(6) YEAR OLD MALE ADMITTED FOR CHEST PAIN; PREVIOUS HISTORY INCLUDES CORONARY ARTERY DISEASE WITH STENT PLACEMENT. EKG: (B)(6) 2014 6:40 AM SINUS RHYTHM WITH EVIDENCE OF LEFT BUNDLE BRANCH BLOCK, UNCHANGED FROM PREVIOUS EKG. PT WAS ADVISED TO BE ADMITTED FOR "OBSERVATION" BASED ON HIS HISTORY OF CORONARY DISEASE BUT PT LEFT HOSP AGAINST MEDICAL ADVICE. HIS FINAL EXAM WAS PAIN-FREE AND VITALS WERE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296986 KIT, TRIAGE, CARDIAC TNI CARIDAC MARKER TEST MMI ALERE SAN DIEGO INC 97021HS W56232RB

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR ALPRAZOLAM| OXYCODONE| ATENOLOL| METFORMIN HCL| FLOMAX| LIPITOR| PRONTONIX| ASPIRIN| DULERA| ALBUTEROL| PLAVIX| METOPROLOL