BD CTGCTV2 FOR BD MAX¿ SYSTEM (US
Report
- Report Number
- 1119779-2023-00245
- Event Type
- Malfunction
- Date Received
- March 9, 2023
- Date of Event
- February 7, 2023
- Report Date
- April 21, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- LSL
- UDI-DI
- 00382904439040
- PMA / PMN Number
- K182692
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MEDICAL DEVICE TYPE: LSL, MKZ, OUY. INITIAL REPORTER PHONE# AND ADDRESS: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX¿ CTGCTV2 US KIT (REF. (B)(4) LOTS 2158646, 2060181, 2020628 AND 2011762 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¿ CTGCTV2 US KIT INDICATED THAT LOTS 2158646, 2060181, 2020628 AND 2011762 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT ONE PATIENT TESTED SEVERAL TIMES, WITH POSITIVE RESULTS FOR CHLAMYDIA (CT) AND/OR GONORRHEA (GC) TARGETS WITH THE BD MAX¿ CTGCTV2 US KIT. ACCORDING TO THE COMPLAINT TEXT, THE PATIENT DID NOT AGREE WITH THE RESULTS AND WENT TO ANOTHER MOLECULAR TEST PROVIDER, WHERE THE RESULTS WERE NEGATIVE FOR CHLAMYDIA AND GONORRHEA. ONLY KIT LOT 2158646 WAS ORIGINALLY PROVIDED FOR THE COMPLAINT BUT ANALYSIS OF THE CUSTOMER DATA REVEALED THAT KIT LOTS 2060181, 2020628 AND 2011762 WERE ALSO USED TO TEST THE SAMPLES AND WERE THEREFORE INCLUDED IN THE INVESTIGATION. CUSTOMER PROVIDED SEVERAL RUNS FOR THE INVESTIGATION, BUT ONLY SAMPLES FROM RUNS 155 POSITION A8, 333 POSITION A10, 437 POSITION A8 AND 555 POSITION 9 WERE MENTIONED BY THE CUSTOMER IN THE COMPLAINT TEXT, THUS ONLY THESE FOUR RUNS WERE ANALYZED. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED OF ALL FOUR SAMPLES SHOWED NO ANOMALY OF THE AMPLIFICATION CURVES. THE SAMPLES APPEAR TO BE TRUE CT AND/OR GC POSITIVE SAMPLES. THE DISCREPANCY OBTAINED WITH THE OTHER MOLECULAR PLATFORM USED MIGHT BE ATTRIBUTABLE TO EACH ASSAY LIMIT OF DETECTION THAT CAN VARY. BASED ON THE DATA AND INFORMATION PROVIDED, THE CUSTOMER¿S POSITIVE RESULTS APPEAR TO BE TRUE POSITIVE RESULTS. OVERALL, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD MAX CTGCTV2 US KIT LOTS 2158646, 2060181, 2020628 AND 2011762. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.
IT WAS REPORTED THAT WHILE USING THE BD CTGCTV2 FOR BD MAX¿ SYSTEM (US) THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: QUANTITY RECEIVED AND QUANTITY AFFECTED: 1. WAS THIS ISSUE INVOLVING PATIENT OR NONPATIENT SAMPLES? 1 PATIENT SAMPLE IS AFFECTED. MAX CTGCTV2 US - 443904_2158646 - FALSE POSITIVE.
IT WAS REPORTED THAT WHILE USING THE BD CTGCTV2 FOR BD MAX¿ SYSTEM (US) THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: QUANTITY RECEIVED AND QUANTITY AFFECTED: 1. WAS THIS ISSUE INVOLVING PATIENT OR NONPATIENT SAMPLES? 1 PATIENT SAMPLE IS AFFECTED. MAX CTGCTV2 US - 443904_2158646 - FALSE POSITIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 140178 | BD CTGCTV2 FOR BD MAX¿ SYSTEM (US | NA | LSL | BECTON, DICKINSON & CO. (SPARKS) | 443904 | 2158646 | 00382904439040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |