BD CTGCTV2 FOR BD MAX¿ SYSTEM (US
Report
- Report Number
- 3007420875-2023-00059
- Event Type
- Malfunction
- Date Received
- June 13, 2023
- Date of Event
- May 16, 2023
- Report Date
- June 15, 2023
- Manufacturer
- GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
- Product Code
- LSL
- UDI-DI
- 00382904439040
- PMA / PMN Number
- K182692
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. 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 DISCREPANT RESULTS WHEN USING THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT (REF. (B)(4) FROM LOT: 2151523 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. REVIEW OF THE MANUFACTURING RECORDS OF THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT INDICATED THAT LOT: 2151523 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE RETAIN MATERIAL OF BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT FROM LOT: 2151523 WAS TESTED AND THE RESULTS WERE AS EXPECTED. NO FALSE NEGATIVE RESULT, NOR OTHER ANOMALY, WAS OBTAINED. CUSTOMER COMPLAINED ABOUT FALSE NEGATIVE RESULTS OBTAINED WITH THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT LOT: 2151523. THEY MENTIONED HAVING SEEN TRICHOMONAS ON THE CONCENTRATED URINE SEDIMENT WHEN VIEWED THROUGH A MICROSCOPE BUT OBTAINED NEGATIVE RESULTS WHEN TESTING THESE SAMPLES WITH THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT LOT: 2151523 ON THREE PATIENT SAMPLES. CUSTOMER PROVIDED ONLY A PDF REPORT OF THE CURVES, WITHOUT ANY GRAPH SCALE FOR INVESTIGATION. THE INVESTIGATION WAS THUS LIMITED. THE PDF REPORT SHOWS THAT THE SPC FROM THE THREE SAMPLES AMPLIFIED WITHOUT ANOMALY, AND THERE WAS NO AMPLIFICATION OF THE TV TARGET. THESE OBSERVATIONS SUGGEST THAT THE TESTS PERFORMED AS EXPECTED AND NO REAGENT ISSUE IS SUSPECTED. MOREOVER, LIMITED INFORMATION WAS AVAILABLE ABOUT THE MICROSCOPY METHOD. NONETHELESS, DIFFERENCES IN SENSITIVITY BETWEEN METHODS COULD EXPLAIN THE DISCREPANCY, OR IT IS POSSIBLE THAT INTERPRETATION OF MICROSCOPY RESULTS WAS INCORRECT AND WHAT WAS OBSERVED WAS A DIFFERENT ORGANISM, NOT TRICHOMONAS VAGINALIS DETECTED BY BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION, BD IS UNABLE TO IDENTIFY THE EXACT CAUSE FOR THE CUSTOMER¿S ISSUE. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT LOT: 2151523. 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.
IT WAS REPORTED THAT WHILE USING THE BD CTGCTV2 FOR BD MAX¿ SYSTEM (US THAT THERE WAS A FALSE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS FALSE NEGATIVE RESULTS WITH LOT#: 2151523. CUSTOMER REPORTS FN FOR TRICHOMONAS SP. RESULT WAS CORROBORATED BY GRAM STAIN.
IT WAS REPORTED THAT WHILE USING THE BD CTGCTV2 FOR BD MAX¿ SYSTEM (US THAT THERE WAS A FALSE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS FALSE NEGATIVE RESULTS WITH LOT#: 2151523. CUSTOMER REPORTS FN FOR TRICHOMONAS SP. RESULT WAS CORROBORATED BY GRAM STAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2190307 | BD CTGCTV2 FOR BD MAX¿ SYSTEM (US | N/A | LSL | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) | 443904 | 2151523 | 00382904439040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |