BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISBY MEDICAL COVID-19 POINT OF CARE TEST

    MDR report key: 16455835 · Received February 28, 2023

    Report

    Report Number
    3016608638-2023-00003
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    December 16, 2021
    Report Date
    December 7, 2022
    Manufacturer
    VISBY MEDICAL, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2023, (B)(6): FIRST ATTEMPT TO SEND THE REPORT WAS MADE ON (B)(6) 2023; HOWEVER, IT FAILED TO RECEIVE SECOND AND THIRD ACKNOWLEDGMENTS. TICKET (B)(4) WITH THE EMDR HELP DESK WAS ISSUED. HELP DESK ADVISED TO RESUBMIT. SECOND ATTEMPT TO SEND THE REPORT WAS MADE ON (B)(6) 2023; HOWEVER, IT FAILED TO RECEIVE SECOND AND THIRD ACKNOWLEDGMENTS. TICKET (B)(4) WITH THE EMDR HELP DESK WAS ISSUED. HELP DESK ADVISED THEY RECEIVE AND ERROR WHEN TRYING TO PROCESS THE REPORT. ETQ IT DISCOVERED DISCREPANCY IN URL SERVLET. REQUEST SUBMITTED TO ESG HELP DESK FOR THE UPDATE TO THE CORRECT URL IN THE SERVLET. UPDATE WAS MADE ON TICKET 350943. THIS IS THE THIRD ATTEMPT TO SEND REPORT AFTER THE UPDATE. THE DEVICE WITH THE REPORTED FALSE POSITIVE RESULT WAS REQUESTED BACK FOR INVESTIGATION; HOWEVER, THE CUSTOMER DISCARDED IT. SINCE THE DEVICE WAS NOT RECEIVED, THE ALLEGATION COULD NOT BE CONFIRMED. ON PAGE 12 OF THE INSTRUCTIONS FOR USE UNDER LIMITATIONS, IT STATES THE DEVICE CANNOT IDENTIFY FALSE POSITIVE RESULTS. THERE WILL BE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME AS THE COMPLAINT CANNOT BE CONFIRMED AND ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. VISBY WILL CONTINUE TO MONITOR FOR TRENDS.: TREATMENT/ THERAPY START AND STOP DATES (USE BLOCK TO RECORD THE DATE THAT A DIAGNOSTIC TEST WAS PERFORMED FOR REPORTS THAT INVOLVE AN IN VITRO DIAGNOSTIC PRODUCT.) START DATE: (B)(6) 2021 STOP DATE: (B)(6) 2021

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE PATIENT CAME IN FOR TESTING AND RECEIVED A POSITIVE RESULT ON THE VISBY DEVICE. THE PATIENT WAS IMMEDIATELY RETESTED ON THE SAME DAY ON A SEPARATE VISBY DEVICE WHICH RETURNED A NEGATIVE RESULT. THE SAME SAMPLE WAS USED FOR BOTH VISBY TESTS. THE CUSTOMER STATED THE PATIENT WAS BETWEEN TWENTY TO THIRTY YEARS OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626189 VISBY MEDICAL COVID-19 POINT OF CARE TEST VISBY MEDICAL COVID-19 TEST QJR VISBY MEDICAL, INC. PS-001260 LN21110092

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Unknown VISBY MEDICAL COVID-19 POWER ADAPTERPS-000288.