KIT BD MAX CTGCTV2 US
Report
- Report Number
- 3007420875-2023-00120
- Event Type
- Malfunction
- Date Received
- December 7, 2023
- Date of Event
- November 16, 2023
- Report Date
- January 31, 2024
- 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
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT (REF. (B)(4)) LOT 3172526 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT INDICATED THAT LOT 3172526 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED ONE NON-REPEATABLE TRICHOMONAS POSITIVE RESULT WHEN USING THE BD MAX¿ CTGCTV2 ASSAY. ACCORDING TO THE COMPLAINT TEXT, THE SAME SAMPLE (SAME SAMPLE BUFFER TUBE) WAS TESTED THREE TIMES. THE INITIAL TEST GAVE A TV POSITIVE RESULT (SAMPLE IN POSITION A10/RUN #944) USING THE BD MAX¿ CTGCTV2, THE SECOND TEST GAVE A TV NEGATIVE RESULT (SAMPLE IN POSITION A5/RUN #947) ALSO USING THE BD MAX¿ CTGCTV2 WITH THE SAME KIT LOT 3172526 AND THE THIRD TEST GAVE A TV NEGATIVE RESULT (SAMPLE IN POSITION A12/RUN #946) BUT WITH A BD MAX¿ VAGINAL PANEL ASSAY. CUSTOMER PROVIDED THREE RUN FILES 944, 946 AND 947 FROM INSTRUMENT (B)(6) FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION OF THE POSITIVE RESULT IN THE INITIAL TEST REVEALED A STEP DISLOCATION IN THE RAW PCR SIGNAL IN THE TV TARGET CHANNEL (CY5), RESULTING IN A POSITIVE RESULT FOR TV TARGET. HOWEVER, IT IS UNLIKELY THAT THE STEP DISLOCATION IS DUE TO TRUE AMPLIFICATION, SUGGESTING THAT IT IS NOT A TRUE POSITIVE RESULT. THE REPEAT TEST, USING THE BD MAX¿ VAGINAL PANEL AND BD MAX¿CTGCTV2 ASSAYS SHOW NO AMPLIFICATION AND NO ANOMALY. NEVERTHELESS, IT MUST BE NOTED THAT MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BD WAS UNABLE TO IDENTIFY A CAUSE FOR THE ATYPICAL PCR SIGNAL IN THE INITIAL TEST, BUT THIS SEEMED TO BE AN ISOLATED EVENT. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT LOT 3172526. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.
D2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHEN USING THE KIT BD MAX CTGCTV2 US THE USER RECEIVED A POSITIVE RESULT FOR TRICHOMONAS BUT UPON REPEAT A NEGATIVE RESULT WAS RECEIVED. THE NEGATIVE RESULT WAS ALSO RECEIVED IN A VAGINAL PANEL PERFORMED BY THE USER. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHEN USING THE KIT BD MAX CTGCTV2 US THE USER RECEIVED A POSITIVE RESULT FOR TRICHOMONAS BUT UPON REPEAT A NEGATIVE RESULT WAS RECEIVED. THE NEGATIVE RESULT WAS ALSO RECEIVED IN A VAGINAL PANEL PERFORMED BY THE USER. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1366600 | KIT BD MAX CTGCTV2 US | TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM | LSL | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) | UNKNOWN | 00382904439040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |