BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE D-DIMER PANEL

    MDR report key: 14430991 · Received May 18, 2022

    Report

    Report Number
    3013982035-2022-00005
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Report Date
    May 17, 2022
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    GHH
    PMA / PMN Number
    K042890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING OF RETAINED DEVCES OF LOT NUMBER T12496N. RETAINS OF THE COMPLAINT LOT WERE TESTED WITH A POSITIVE CALIBRATOR, NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED. LOT PERFORMED WITHIN SPECIFICATION. MANUFACTURING BATCH RECORDS FOR LOT T12496N WERE REVIEWED AND FOUND THAT THE LOT MET FINAL RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTION ACTION IS REQUIRED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED POOR TRIAGE D-DIMER CORRELATION WITH ACL ELITE. THEY STATED THAT THE CORRELATION FAILED. RESULTS: SAMPLE NUMBER 6,7,8,9,10,12,13,14, AND 15 DID NOT CORRELATE WITH RESPECTIVE CUTOFFS. THE ACL USES A 250 CUT OFF FOR NEGATIVES, ANYTHING BELOW 250 IS CONSIDERED NEGATIVE, ANYTHING ABOVE IS CONSIDERED POSITIVE. PROPOSED CUTOFF FOR TRIAGE IS 350. NO MEDICAL DECISIONS HAVE BEEN MADE FROM THIS DATA ANALYSIS. IT WAS DONE FOR STUDY/IMPLEMENTATION PURPOSES ONLY. NO AE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2754807 TRIAGE D-DIMER PANEL TRIAGE D-DIMER PANEL GHH QUIDEL CARDIOVASCULAR INC. 98100 T12496N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TRIAGE METERPRO PN: 55070, (B)(4)