VISBY MEDICAL SEXUAL HEALTH TEST

Additional Manufacturer Narrative

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

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.