BD MAX¿ VAGINAL PANEL
Received Jan 4, 2022 · Event occurred Dec 6, 2021
Report 3007420875-2021-00066 · MDR key 13155437
Device
Generic name
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Model number
443712Catalog number
443712
Lot number
1203088
Product problems
- False Positive Result
- False Positive Result
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD MAX¿ VAGINAL PANEL A FALSE POSITIVE RESULTS WAS OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " FALSE POSITIVE RESULT FOR TRICHOMONAS VAGINALIS."
Additional Manufacturer Narrative
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
THIS MDR SHOULD BE CONSIDERED CANCELLED. THIS COMPLAINT WAS DETERMINED TO BE A DUPLICATE OF THE COMPLAINT REPORTED UNDER MFR REPORT NUMBER: 1119779-2021-02088.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD MAX¿ VAGINAL PANEL A FALSE POSITIVE RESULTS WAS OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " FALSE POSITIVE RESULT FOR TRICHOMONAS VAGINALIS"