BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE METER PRO

    MDR report key: 13924785 · Received March 26, 2022

    Report

    Report Number
    3013982035-2022-00003
    Event Type
    Injury
    Date Received
    March 26, 2022
    Date of Event
    February 24, 2022
    Report Date
    March 25, 2022
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    KHO
    PMA / PMN Number
    K973547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 0

    THE TRIAGE METERPRO WAS INVESTIGATED IN-HOUSE WITH NO PROBLEM FOUND. THE CUSTOMER'S RETURNED POWER SUPPLY WAS SENT OUT TO THE VENDOR. THE VENDOR CONFIRMED THAT LIQUID RESIDUE LEAKED INTO THE POWER SUPPLY HOUSING CAUSING DAMAGE WHICH COULD LEAD TO ELECTRICAL FAILURES. THE ROOT CAUSE WAS DETERMINED TO BE ISSUE WITH FLUIDS GETTING INTO UNIT. NO CORRECTION ACTION IS REQUIRED.

    Description of Event or Problem · 0

    ON (B)(6) 2022: CUSTOMER REPORTED NURSE OBTAINED A SHOCK WHEN PLUGGING IN TRIAGE METER. TS REQUESTED ADDITIONAL INFORMATION TO UNDERSTAND "SHOCK" (IE. STATIC SHOCK OR ELECTRICAL). CUSTOMER ALSO STATED MACHINE BLEW UP BUT PHOTOS OF THE METER SHOW IT IS FULLY INTACT WITH NO SIGNS OF SMOKE OR HEAT DAMAGE. ON 03/3/22: TECHNICAL SUPPORT REQUESTED ADDITIONAL INFORMATION FROM THE ACCOUNT, THE NURSE RESPONDED WITH THE FOLLOWING: "I SUSTAINED AN ELECTRIC SHOCK TO MY LEFT HAND WHEN PLUGGING IN THE TRIAGE METER. MY FINGERS WERE PAINFUL FOR SOME TIME AFTERWARDS. I ALSO HAD A TINGLING PAIN FROM MY WRIST TO MY ELBOW. THIS RESOLVED COMPLETELY AFTER 3 DAYS. I DID NOT SEEK ANY MEDICAL ATTENTION. WITH HINDSIGHT I THINK I SHOULD HAVE VISITED A&E TO BE CHECKED. I COMPLETED AN INCIDENT REPORT AND WENT STRAIGHT OUT TO SEE MY PATIENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587942 TRIAGE METER PRO TRIAGE METER PRO KHO QUIDEL CARDIOVASCULAR INC. 55071

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other