MAUDE Adverse Event Report: VISBY MEDICAL, INC. VISBY MEDICAL SEXUAL HEALTH TEST

Model Number	PS-001402
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Sexually Transmitted Infection (4555)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was requested back for further evaluation however the customer advised that 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 limitations 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.
Event or Problem Description
Customer reported a discrepant result for a patient's chlamydia status.The visby medical sexual health test was interpreted as negative for chlamydia.The results from an additional test were positive for chlamydia.The vaginal samples for the two tests were collected by the patient on the same day.A third test was not performed.

• Brand Name: VISBY MEDICAL SEXUAL HEALTH TEST
• Common Device Name: VISBY MEDICAL SEXUAL HEALTH TEST
• Manufacturer (Section D): VISBY MEDICAL, INC.; 3010 north first street; san jose CA 95134
• Manufacturer (Section G): VISBY MEDICAL; 3010 north first street; san jose CA 95134
• Manufacturer Contact: monica nachbar ; 3010 north first street; san jose, CA 95134 ; 8334684729
• MDR Report Key: 22374060
• Report Number: 3016608638-2025-00002
• Device Sequence Number: 12766634
• Product Code: QEP
• UDI-Device Identifier: 10810031720061
• UDI-Public: (01)10810031720061(10)LN25020099(17)260103
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K220407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2026
• Device Model Number: PS-001402
• Device Catalogue Number: PS-300681
• Device Lot Number: LN25010009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female