BD MAX¿ VAGINAL PANEL
Report
- Report Number
- 3007420875-2022-00060
- Event Type
- Malfunction
- Date Received
- October 5, 2022
- Date of Event
- September 28, 2022
- Report Date
- December 21, 2022
- Manufacturer
- GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
- Product Code
- PQA
- UDI-DI
- 00382904437121
- PMA / PMN Number
- SEE H.10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PMA/510(K)#: DEN160001. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR HIGH POSITIVITY RATE FOR THE CANDIDA TARGET WITH THE BD MAX VAGINAL PANEL (REF. 443712) LOT 2110913 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX VAGINAL PANEL INDICATED THAT THE LOT 2110913 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. MORE DETAILS ABOUT THE COMPLAINT WERE REQUESTED BUT NO MORE INFORMATION WAS PROVIDED THUS THE INVESTIGATION WAS LIMITED. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED ACROSS SAMPLES INCLUDED IN BOTH RUNS. BOTH RUNS CONTAINING 20 SAMPLES TESTED WITH THE BD MAX VAGINAL PANEL ASSAY ON INSTRUMENT BD MAX CT2684. MULTIPLE SAMPLES GAVE A POSITIVE RESULT FOR THE CGROUP TARGET IN BOTH RUNS AND BASED ON THIS INFORMATION, IT WAS ASSUMED THAT THE COMPLAINT WAS RELATED TO THAT SPECIFIC TARGET. NO OTHER CANDIDA TARGET WAS POSITIVE. AMONG THE (B)(4) SAMPLES TESTED IN BOTH RUNS, 10 GAVE A POSITIVE CGROUP RESULT WITH AMPLIFICATION CURVES SUGGESTING TRUE POSITIVE RESULTS. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. THE DATABASE OF INSTRUMENT CT2684 INCLUDED 136 RUNS TESTED WITH VARIOUS ASSAYS OVER A PERIOD OF 3 MONTHS. (B)(4) SAMPLES WERE TESTED WITH THE BD MAX¿ VAGINAL PANEL ASSAY, ALL USING THE SAME KIT LOT 2110913. DATA ANALYSIS REVEALED THAT, WHEN EXCLUDING THE POSITIVE CONTROLS SAMPLES, THE POSITIVITY RATE FOR THE CGROUP TARGET VARIED IN TIME SUGGESTING THAT THE ISSUE IS NOT LINKED SPECIFICALLY TO THE KIT LOT. ON SEPTEMBER 27TH, CUSTOMER PERFORMED ENVIRONMENTAL MONITORING USING A SINGLE SAMPLE (SWAB OF MULTIPLE ZONES) AND IT GAVE A NEGATIVE RESULT SUGGESTING THAT THE ISSUE IS NOT LINKED TO HIGH LEVEL OF ENVIRONMENTAL CONTAMINATION. . OVERALL, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD MAX VAGINAL PANEL LOT 2110913. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. . BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT WHILE USING THE BD MAX¿ VAGINAL PANEL THERE WAS A HIGH POSITIVITY RATE FOR THE CANDIDA TARGET. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS MVP ASSAY "HIGH POSITIVITY RATE FOR CANDIDA TARGET", ACCORDING TO THEIR PROVIDERS.
IT WAS REPORTED THAT WHILE USING THE BD MAX¿ VAGINAL PANEL THERE WAS A HIGH POSITIVITY RATE FOR THE CANDIDA TARGET. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS MVP ASSAY "HIGH POSITIVITY RATE FOR CANDIDA TARGET", ACCORDING TO THEIR PROVIDERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2304368 | BD MAX¿ VAGINAL PANEL | VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM | PQA | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) | 443712 | UNKNOWN | 00382904437121 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |