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

Model Number	PS-000175
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
(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.

• Brand Name: VISBY MEDICAL SEXUAL HEALTH CLICK TEST
• Common Device Name: SEXUAL HEALTH TEST
• Manufacturer (Section D): VISBY MEDICAL, INC.; 3010 north first street; san jose CA 95134
• Manufacturer (Section G): VISBY MEDICAL, INC.; 3010 north first street; san jose CA 95134
• Manufacturer Contact: delia williams ; 3010 north first street; san jose, CA 95134 ; 8334684729
• MDR Report Key: 16931011
• Report Number: 3016608638-2023-00007
• Device Sequence Number: 6805561
• Product Code: QEP
• UDI-Device Identifier: 00810031720002
• UDI-Public: 00810031720002
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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): 05/01/2023

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: 05/03/2023
• Device Model Number: PS-000175
• Device Catalogue Number: PS-000688
• Device Lot Number: LN23010029
• 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: 04/12/2023
• Initial Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VISBY MEDICAL COVID-19 POWER ADAPTERPS-000288; ZEPTOMETRIXPART #NATCTNGTV-POS-IVDLOT #330132
• Patient Sex: Unknown