BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 5211075 · Received November 9, 2015

    Report

    Report Number
    2027969-2015-00909
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    July 13, 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

    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 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 LATIN AMERICA AFFILIATE HAD NOT BEEN ESCALATED TO ALERE (B)(6) (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 WW, PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF NECK PAIN SIMILAR TO WHAT CAUSED A RECENT "ATC". TRIAGE TEST AT 0340 SHOWED THE FOLLOWING RESULTS: CKMB=1.5 NG/ML, TNI < 0.05 NG/ML, MYO=114 NG/ML AND D-DIMER=289 NG/ML. LABORATORY TESTS PERFORMED AT 0354 SHOWED THE FOLLOWING: CKMB=2.10 NG/ML, TNI <0.01NG/ML, MYO=99 NG/ML AND D-DIMER=744.4 NG/ML. AT 0900, A NEW TRIAGE TEST WAS PERFORMED: CKMB=1.7 NG/ML, TNI <0.05 NG/ML, MYO=146 NG/ML, D-DIMER=239 NG/ML AND BNP <5.0 NG/ML. THE D-DIMER WAS RETESTED WITH THE SAME 0900 SAMPLE AND THE RESULT WAS 222 NG/ML. NEW LABORATORY TESTS AT 1103 SHOWED A D-DIMER RESULT OF 700.2 NG/ML. TO CLARIFY THE DIFFERENCE, A ANGIOGRAPHY COMPUTED TOMOGRAPHY (CT) OF THE THORAX WAS PERFORMED WHICH WAS NEGATIVE FOR PULMONARY EMBOLISM (PE). THE PATIENT WAS DISCHARGED. 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
    740148 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)