BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE D-DIMER PANEL

    MDR report key: 8805651 · Received July 18, 2019

    Report

    Report Number
    3013982035-2019-00017
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    June 7, 2019
    Report Date
    July 25, 2019
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    GHH
    PMA / PMN Number
    K042890
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED: INCLUDED PATIENT GENDER IN SECTION A3. DATES LISTED IN SECTION B3, B5, B6 AND D11 WERE INCORRECT IN THE INITIAL MDR REPORT. UPDATED PATIENT CODE IN H6.

    Description of Event or Problem · 0

    CUSTOMER REPORTED OBSERVING ELEVATED D-DIMER RESULTS ON THE TRIAGE SYSTEM FOR A PATIENT. PATIENT WAS TESTED ON TRIAGE AND YIELDED A POSITIVE D-DIMER RESULT OF 1100NG/ML. SITES' REFERENCE RANGE IS 0-600NG/ML. CUSTOMER STATED NO OTHER COAGULATION TESTS WERE CONDUCTED. CUSTOMER STATED PATIENT HAD A CHEST X-RAY DONE, NO PE IDENTIFIED. PATIENT ALSO HAD A "CTA CHEST PE WITH CONTRAST DONE, NEGATIVE FOR PE". PATIENT WAS FOUND TO HAVE AN ASCENDING THORACIC AORTIC ANEURYSM AND "ATHEROSCLEROTIC CALCIFICATION SEEN, HEART ENLARGED".

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING WITH RETAINS OF DEVICE LOT T10094N. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED, LOT PERFORMED PROPERLY. MANUFACTURING BATCH RECORDS FOR THE LOT WERE REVIEWED, LOT MET FINAL RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SLIGHTLY ELEVATED D-DIMER RESULTS FOR ONE PATIENT. PATIENT 1 ON (B)(6) 2019- 1100NG/ML RESULT DATA- FEMALE PATIENT, CHEST X-RAY DONE, NO PE, CTA CHEST PE WITH CONTRAST DONE, NEGATIVE FOR PE. AN ASCENDING THORACIC AORTIC ANEURYSM DISCOVERED, SURGICAL CONSULT SUGGESTED. ATHEROSCLEROTIC CALCIFICATION SEEN, HEART ENLARGED. NO HEMOLYSIS OF SAMPLE. CTA CHEST PE WITH CONTRAST IS MENTIONED IN OUTCOMES TO ADVERSE EVENT. REFERENCE RANGE 0-600NG/ML. NO CRITICAL VALUE. NO TREATMENT ADMINISTERED/WITHHELD BASED ON THE TRIAGE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597462 TRIAGE D-DIMER PANEL TRIAGE D-DIMER PANEL GHH QUIDEL CARDIOVASCULAR INC. 98100 T10094N

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TRIAGE METERPRO PN: 55070 LOT NUMBER: 76877| TRIAGE METERPRO PN: 55070, SERIAL NUMBER: (B)(6).