BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL 25T

    MDR report key: 6725849 · Received July 19, 2017

    Report

    Report Number
    2027969-2017-00120
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Date of Event
    May 15, 2017
    Report Date
    June 22, 2017
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DAP
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING WITH RETAINED DEVICES OF LOT W62463B. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR THE LOT WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATION BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING. THIS EVENT IS BEING REPORTED AS PART NUMBER 97300EU IS SAME/SIMILAR TO 510 (K): K080269.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING EVENTS OCCURRING ON ONE PATIENT. THE CUSTOMER REPORTED BEING CONCERNED WITH THE D-DIMER RESULTS. ON (B)(6) 2017, THE PATIENT ARRIVED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN. AN INITIAL DRAW WAS PERFORMED AND BOTH WHOLE BLOOD AND PLASMA WERE COLLECTED IN EDTA: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505622 TRIAGE PROFILER SOB PANEL 25T CARDIOPROFILER PANEL DAP ALERE SAN DIEGO, INC. 97300EU W62463B

    Patients

    Seq Age Sex Outcome Treatment
    1 TRIAGE METERPRO, PN 55070, SERIAL# (B)(4)| TRIAGE METERPRO, PN 55070, SERIAL# (B)(4)| TRIAGE METERPRO, PN 55070, SERIAL# (B)(4)