BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE D-DIMER PANEL

    MDR report key: 7507654 · Received May 11, 2018

    Report

    Report Number
    3013982035-2018-00012
    Event Type
    Malfunction
    Date Received
    May 11, 2018
    Report Date
    June 14, 2018
    Manufacturer
    QUIDEL CARDIOVASCULAR, INC.
    Product Code
    GHH
    PMA / PMN Number
    K042890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: CUSTOMER RETURNED THE METER INVOLVED IN THE EVENT ((B)(4)). THE METERS' MEMORY HISTORY WAS REVIEWED IN ATTEMPTS TO OBTAIN THE DEVICE LOT NUMBER USED DURING THE CUSTOMERS REPORTED DISCREPANCY. A LOT NUMBER WAS IDENTIFIED, TRIAGE D-DIMER LOT W63282RB. CUSTOMERS COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W63282RB WITH IN-HOUSE TRIAGE METERS AND CUSTOMERS RETURNED METER. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED. RETAIN DEVICES AND CUSTOMERS RETURNED METER PERFORMED PROPERLY. MANUFACTURING BATCH RECORDS FOR THE LOT 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 (98100EU) IS NOT APPROVED IN THE UNITED STATES, THIS EVENT IS BEING REPORTED AS THE DEVICE IS SAME/SIMILAR TO CATALOG NUMBER 98100, 510(K) NUMBER K042890.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING. ALTHOUGH THIS CATALOG NUMBER (98100EU) IS NOT APPROVED IN THE UNITED STATES, THIS EVENT IS BEING REPORTED AS THE DEVICE IS SAME/SIMILAR TO CATALOG NUMBER 98100, 510(K) NUMBER K042890.

    Description of Event or Problem · 1

    CUSTOMER REPORTED MULTIPLE DISCREPANT RESULTS ON THE TRIAGE D-DIMER PANEL WITH ONE PATIENT. CUSTOMER STATED THEY TESTED THE PATIENT ON TRIAGE METERPRO S/N (B)(4) AND OBTAINED RESULTS AROUND 300-400NG/ML FOR D-DIMER BUT ON A SECOND TRIAGE INSTRUMENT (SERIAL NUMBER NOT PROVIDED) OBTAINED RESULTS AROUND 800NG/ML. THE PATIENT SAMPLE WAS THEN SENT TO THE LABORATORY AND WAS CONFIRMED TO BE AROUND 800 NG/ML. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351464 TRIAGE D-DIMER PANEL TRIAGE D-DIMER PANEL GHH QUIDEL CARDIOVASCULAR, INC. 98100EU W63282RB

    Patients

    Seq Age Sex Outcome Treatment
    1 TRIAGE METERPRO (PN: (B)(4)): S/N (B)(4)