BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 7748824 · Received August 3, 2018

    Report

    Report Number
    3013982035-2018-00022
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Date of Event
    June 19, 2018
    Report Date
    August 3, 2018
    Manufacturer
    QUIDEL CARDIOVASCULAR, INC.
    Product Code
    DAP
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING WITH RETAINS OF DEVICE LOT W64169B. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED, LOT PERFORMED PROPERLY. MANUFACTURING BATCH RECORDS FOR THE LOT WERE REVIEWED, 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCORDANT D-DIMER RESULTS FOR ONE PATIENT. TWO SAMPLES WERE COLLECTED FROM THE PATIENT AT THE SAME TIME. EDTA SAMPLE WAS RAN ON TRIAGE AND SERUM SAMPLE WAS RAN ON ACL TOP 550. RESULTS ARE BELOW: SAMPLE 1 : 477 NG/ML TRIAGE VS. 741 NG/ML LAB. SAMPLE 2: 340 NG/ML TRIAGE VS. 678 NG/ML LAB. ALTHOUGH REQUESTED, PATIENT OUTCOME WAS NOT PROVIDED. CUSTOMER STATED THERE WAS NO DELAY IN PATIENT TREATMENT AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590095 TRIAGE PROFILER SOB PANEL TRIAGE PROFILER SOB PANEL DAP QUIDEL CARDIOVASCULAR, INC. 97300EU W64169B

    Patients

    Seq Age Sex Outcome Treatment
    1