BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISBY MEDICAL SEXUAL HEALTH CLICK TEST

    MDR report key: 16931011 · Received May 15, 2023

    Report

    Report Number
    3016608638-2023-00007
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    April 12, 2023
    Report Date
    May 1, 2023
    Manufacturer
    VISBY MEDICAL, INC.
    Product Code
    QEP
    UDI-DI
    00810031720002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6)2023, (B)(6): THE NEGATIVE RESULTS WERE CONFIRMED VIA THE IMAGE OF THE TEST PROVIDED BY THE CUSTOMER. THE DEVICE WAS REQUESTED BACK FOR FURTHER EVALUATION HOWEVER THE CUSTOMER ADVISED THE DEVICE WAS DISCARDED. SINCE THE DEVICE WAS NOT RETURNED, THE ROOT CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED. REFER TO PAGE 8 AND 9 OF THE INSTRUCTIONS FOR USE (IFU) FOR THE LIST OF LIMITATION WHICH CONTAINS INFORMATION ON ERRONEOUS RESULTS (LIMITATIONS 4-6), INTERPRETING THE TEST RESULTS (LIMITATION 13), AND ADVERSE SOCIOECONOMIC IMPACTS (LIMITATION 14). THERE WILL BE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME AS THE 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: 12 APR 2023 STOP DATE: 12 APR 2023 H3 OTHER TEXT : NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THE CUSTOMER RECEIVED NEGATIVE RESULTS FOR TWO (CHLAMYDIA AND GONORRHOEAE) OF THE THREE (TRICHOMONAS WAS POSITIVE) INDICATORS WHEN RUNNING A POSITIVE CONTROL ON A VISBY STI TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185069 VISBY MEDICAL SEXUAL HEALTH CLICK TEST SEXUAL HEALTH TEST QEP VISBY MEDICAL, INC. PS-000175 LN23010029 00810031720002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown VISBY MEDICAL COVID-19 POWER ADAPTERPS-000288| ZEPTOMETRIXPART #NATCTNGTV-POS-IVDLOT #330132