BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIAC PANEL

    MDR report key: 8489607 · Received April 5, 2019

    Report

    Report Number
    3013982035-2019-00006
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    February 12, 2019
    Report Date
    April 5, 2019
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING WITH RETAINS AND RETURNS OF DEVICE LOT W64711B. NO ISSUES WITH RECOVERY WERE OBSERVED; LOT PERFORMED PROPERLY. MANUFACTURING BATCH RECORDS FOR THE LOT WERE REVIEWED, LOT MET RELEASE SPECIFICATIONS. THE ROOT CAUSE COULD NOT BE DETERMINED. 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 THE FOLLOWING OCCURRING FOR ONE PATIENT. ON (B)(6) 2019, A PATIENT PRESENTED TO THE CUSTOMERS FACILITY WITH RESPIRATORY CONGESTION, FATIGUE AND CHEST ACHINESS. PATIENT SAMPLE WAS TESTED ON TRIAGE AND RESULTED AT 15:09 WITH THE FOLLOWING: CKMB=15.2, MYO=133, TNI =0.63. SITE'S CUT-OFFS FOR CKMB = 4.3NG/ML AND TNI = </=0.05NG/ML. CUSTOMER STATED THAT SHE BELIEVES THAT THEIR MYO CUTOFF IS THE SAME AS STATED IN THE PACKAGE INSERT (<107NG/ML). THE PATIENT WAS TRANSFERRED AND ADMITTED TO (B)(6) HOSPITAL. PATIENT SAMPLE WAS TESTED AT THE HOSPITAL AND RESULTED AT 16:16 WITH THE FOLLOWING: CKMB= </=6NG/ML., TNI = </=0.05NG/ML. HOSPITAL REFERENCE RANGE FOR TNI IS </=0.05NG/ML. CUSTOMER DID NOT KNOW THE CKMB REFERENCE RANGE BUT STATED THE PATIENTS RESULT WAS NORMAL. PHYSICIAN AT THE HEART HOSPITAL SENT PATIENT TO THE CATH LAB. RESULT OF THE CATH PROCEDURE WAS THAT EVERYTHING WAS NORMAL. CUSTOMER COULD NOT SPECIFY FOR CERTAIN THAT THE PATIENT RECEIVED THE CATH PROCEDURE DUE TO THE RESULTS ON THE TRIAGE SYSTEM OR IF IT WAS DUE TO THE SYMPTOMS PLUS THE RESULTS, OR OTHERWISE AS SHE CANNOT SPEAK FOR THE HEART HOSPITAL PHYSICIAN WHO ORDERED THE PROCEDURE, BUT SHE DID INDICATE IT SEEMED LIKELY. CUSTOMERS UNDERSTANDING IS THAT "OTHER TESTS" HAD BEEN PERFORMED AND THE PHYSICIAN HAD DECIDED ON THE CATH PROCEDURE. CUSTOMER COULD NOT SPECIFY WHAT THE "OTHER TESTS" WERE. CUSTOMER SITE BECAME AWARE OF THE DISCREPANCY (B)(6) 2019 WHEN THE PATIENT CAME IN FOR A FOLLOW UP AND DISCUSSED EVENTS WITH THE PHYSICIAN. DESPITE MULTIPLE ATTEMPTS, FURTHER INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280593 TRIAGE CARDIAC PANEL TRIAGE CARDIAC PANEL MMI QUIDEL CARDIOVASCULAR INC. 97000HS W64711B

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O