BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISBY MEDICAL SEXUAL HEALTH TEST

    MDR report key: 21606711 · Received March 14, 2025

    Report

    Report Number
    3016608638-2025-00001
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    February 19, 2025
    Report Date
    March 13, 2025
    Manufacturer
    VISBY MEDICAL, INC.
    Product Code
    QEP
    PMA / PMN Number
    K220407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS REQUESTED BACK FOR FURTHER EVALUATION HOWEVER THE CUSTOMER ADVISED THE DEVICE WAS NOT AVAILABLE. SINCE THE DEVICE WAS NOT RETURNED, THE ROOT CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED. REFER TO PAGE 13 AND 14 OF THE INSTRUCTIONS FOR USE (IFU) FOR THE LIST OF LIMITATION WHICH CONTAINS INFORMATION ON ERRONEOUS RESULTS (LIMITATIONS 4-8), AND INTERPRETING THE TEST RESULTS (LIMITATION 13). 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. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL OR A HEALTH PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. 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) 2025. STOP DATE: (B)(6) 2025.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A DISCREPANT RESULT FOR PATIENT'S CHLAMYDIA STATUS. THE VISBY MEDICAL SEXUAL HEALTH TEST WAS INTERPRETED AS POSITIVE FOR BOTH GONORRHEA AND TRICHOMONAS BUT NEGATIVE FOR CHLAMYDIA. PATIENT WAS CONSIDERED HIGH RISK BY THE TREATING PHYSICIAN, SO A BACKUP SWAB WAS SENT TO A LABORATORY FOR ADDITIONAL TESTING. THE RESULTS FROM ADDITIONAL TEST WERE POSITIVE FOR CHLAMYDIA. THE VAGINAL SAMPLES FOR THE TWO TESTS WERE COLLECTED BY THE PATIENT ON THE SAME DAY. THE PATIENT WAS INITIALLY TREATED FOR GONORRHEA AND TRICHOMONAS BASED ON THE VISBY MEDICAL TEST RESULTS. TREATMENT FOR CHLAMYDIA WAS DELAYED. PER THE TREATING PHYSICIAN, THE PATIENT WAS NOT INJURED DUE TO THE CONFLICTING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925962 VISBY MEDICAL SEXUAL HEALTH TEST VISBY MEDICAL SEXUAL HEALTH TEST QEP VISBY MEDICAL, INC. PS-001402 LN24090125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown