BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE D-DIMER PANEL

    MDR report key: 19716622 · Received July 10, 2024

    Report

    Report Number
    3013982035-2024-00011
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    May 8, 2024
    Report Date
    July 10, 2024
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    GHH
    PMA / PMN Number
    K042890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT OF CORRELATION ISSUES WITH D-DIMER WAS NOT REPLICATED WITH IN-HOUSE RETAIN TESTING OF TRIAGE D-DIMER LOT T14826 WITH AN IN-HOUSE CALIBRATOR. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED, THE LOT PERFORMED AS EXPECTED. REVIEWED THE BATCH RECORD FOR TRIAGE D-DIMER LOT T14826. THE LOT MET ALL FINAL RELEASE SPECIFICATIONS. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. THE CASE DETAILS WERE REVIEWED ALONG WITH THE COMPLAINT HISTORY OF THIS PRODUCT FOR THE REPORTED FAILURE MODE; NO ISSUES WERE IDENTIFIED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AN NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    EVENT OCCURRED IN THE USA. OCCURRED ON (B)(6) 2024. CUSTOMER REPORTED POOR TRIAGE D-DIMER CORRELATION WITH SYSMEX CA 660 WITH 3 SAMPLES. NO PATIENT DIAGNOSIS OR OUTCOME PROVIDED. NO AE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2347238 TRIAGE D-DIMER PANEL TRIAGE D-DIMER PANEL GHH QUIDEL CARDIOVASCULAR INC. 98100 T14826N

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown