BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISBY MEDICAL COVID-19 POINT OF CARE TEST

    MDR report key: 16455823 · Received February 28, 2023

    Report

    Report Number
    3016608638-2023-00001
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    October 7, 2021
    Report Date
    December 7, 2022
    Manufacturer
    VISBY MEDICAL, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2023, DELIA WILLIAMS: SECOND AND THIRD ACKNOWLEDGMENT STILL NOT RECEIVED. 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. SIXTH ATTEMPT TO SEND REPORT AFTER THE UPDATE. (B)(6) 2023, DELIA WILLIAMS: SECOND AND THIRD ACKNOWLEDGMENT STILL NOT RECEIVED. (B)(6) 2023, DELIA WILLIAMS: SECOND AND THIRD ACKNOWLEDGMENT STILL NOT RECEIVED. FOURTH ATTEMPT TO SEND THE REPORT AS REQUESTED BY VISBY IT. (B)(6) 2023, DELIA WILLIAMS: FIRST ATTEMPT TO SEND THE REPORT WAS MADE ON 07 FEB 2023; HOWEVER, IT FAILED TO RECEIVE SECOND AND THIRD ACKNOWLEDGMENTS. TICKET 349322 WITH THE EMDR HELP DESK WAS ISSUED. HELP DESK ADVISED TO RESUBMIT. SECOND ATTEMPT TO SEND THE REPORT WAS MADE ON 10 FEB 2023; HOWEVER, IT FAILED TO RECEIVE SECOND AND THIRD ACKNOWLEDGMENTS. TICKET 349523 WITH THE EMDR HELP DESK WAS ISSUED. HELP DESK ADVISED THEY RECEIVE AND ERROR WHEN TRYING TO PROCESS THE REPORT. 16 FEB 2023 IS THE THIRD ATTEMPT TO SEND THE REPORT. (B)(6) 2023, DELIA WILLIAMS: THE DEVICE WAS REQUESTED BACK FOR INVESTIGATION. HOWEVER, THE DEVICE WITH FALSE POSITIVE RESULT WAS NOT RECEIVED. 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. C4: TREATMENT/ THERAPY START AND STOP DATES (USE BLOCK C4 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 THAT ONE VISBY DEVICE RETURNED A POSITIVE RESULT AND UPON RETESTING ON A SEPARATE VISBY DEVICE, RESULT WAS NEGATIVE. THE SAME SAMPLE WAS USED FOR BOTH TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717000 VISBY MEDICAL COVID-19 POINT OF CARE TEST VISBY MEDICAL COVID-19 TEST QJR VISBY MEDICAL, INC. PS-001260 LN21080308

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Prefer Not To Disclose VISBY MEDICAL COVID-19 POWER ADAPTERPS-000288