BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 6278084 · Received January 25, 2017

    Report

    Report Number
    2027969-2017-00023
    Event Type
    Malfunction
    Date Received
    January 25, 2017
    Date of Event
    January 17, 2017
    Report Date
    January 17, 2017
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DAP
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W62214. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT W62214 WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. ALTHOUGH THIS CATALOG NUMBER (97300EU) IS NOT APPROVED IN THE UNITED STATES, THIS EVENT IS BEING REPORTED AS THE DEVICE IS SAME/SIMILAR TO CATALOG NUMBER 97300, 510(K) NUMBER K080269.

    Additional Manufacturer Narrative · 1

    CORRECTIONS: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER PORVIDED THE FOLLOWING EVENTS OCCURRING ON (B)(6) 2017. PATIENT PRESENTED WITH MID THORACIC BACK PAIN THAT WAS WORSE ON INSPIRATION. NO CALF TENDERNESS OR SWELLING. OCCURRED THREE DAYS AFTER AIR TRAVEL. TRIAGE D-DIMER RESULT OF LESS THAN 100 NG/ML. FACILITY UNABLE TO PROVIDE TRIAGE D-DIMER CUTOFF BUT CUSTOMER STATED THIS WAS A NORMAL RESULT. FOUR AND A HALF HOURS LATER, SIEMENS INNOVANCE D-DIMER RESULT OF 950 NG/ML (1.9MG/L FEU = 950 NG/ML DDU). FACILITY SIEMENS D-DIMER CUTOFF IS LESS THAN 0.5 MG/L. NO INFORMATION ON TREATMENT OR INTERVENTION AVAILABLE. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59695 TRIAGE PROFILER SOB PANEL CARDIOPROFILER PANEL DAP ALERE SAN DIEGO, INC. W62214

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR