BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 5211014 · Received November 9, 2015

    Report

    Report Number
    2027969-2015-00906
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    July 12, 2015
    Report Date
    July 22, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT WAS ESTIMATED AS (B)(6) 2015 SINCE IT WAS REPORTED ON (B)(6) 2015 AS OCCURRING "LAST WEEK". D2B PROCODE (CONTINUED): DAP, DDR, JHX, MMI. INVESTIGATION/CONCLUSION: THE CUSTOMER DID NOT PROVIDE A LOT NUMBER OR RETURN ANY PRODUCTS FOR INVESTIGATION. SINCE THE PRODUCT(S) ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED AND A LOT NUMBER WAS NOT PROVIDED, MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED AND FURTHER INVESTIGATION OF THE PRODUCT WAS NOT POSSIBLE. FURTHER INVESTIGATION PERFORMED UNDER INTERNAL CAPA-(B)(4) RELATED TO LATE REGULATORY ESCALATION.

    Description of Event or Problem · 1

    THIS EVENT WAS IDENTIFIED AS PART OF AN EVALUATION IN WHICH COMPLAINTS REPORTED TO ALERE (B)(4) AFFILIATE HAD NOT BEEN ESCALATED TO ALERE (B)(4) (ASD) FOR REGULATORY REVIEW AND INVESTIGATION. THERE IS LIMITED INFORMATION AVAILABLE REGARDING THE EVENT AND DUE TO THE TIME GAP BETWEEN WHEN THE COMPLAINT WAS FIRST REPORTED TO WHEN ASD WAS NOTIFIED, ADDITIONAL INFORMATION IS NOT AVAILABLE. THE EVENT OCCURRED IN THE (B)(6). THE CUSTOMER REPORTED THAT THE PATIENT, IDENTIFIED AS XX, PRESENTED TO THE EMERGENCY LAST WEEK (WEEK OF (B)(6) 2015), WITH CHEST PAIN. A TRIAGE EXAM, LABORATORY TESTS AND CORONARY COMPUTED TOMOGRAPHY (CT) WERE REQUESTED. THE TRIAGE RESULTS WERE: CK-MB=1.2 NG/ML, MYO= 55.1 NG/ML, TNI <0.05 NG/ML, BNP=35.0 PG/ML AND D-DIMER=300 NG/ML. THE PATIENT WENT THROUGH A CORONARY CT WITH THE FOLLOWING RESULT: MILD ASTHEOMATOSIS OF THE THORACIC AORTA., ABSENCE OF HEMATOMA OR SIGNS OF DISSECTION. NOTE: EVEN NOT ADDRESSED, IT IS NOTED, AS AN INCIDENTAL FINDING, A DEFECT ON THE FILLING OF THE POSTERIOR SUBSEGMENTAL BRANCH OF THE RIGHT LUNG, CONSISTENT WITH PULMONARY THROMBOEMBOLISM. THE CORONARY CT SHOWED THAT THE "TEP AND THE DDIM WERE FOUND IN THE NORMAL LIMIT". THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. (NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE UNITED STATES.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742089 TRIAGE PROFILER SOB PANEL CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97300EU

    Patients

    Seq Age Sex Outcome Treatment
    1 TRIAGE METERPRO SN (B)(4)