BD COR¿ MX
Report
- Report Number
- 1119779-2025-00272
- Event Type
- Malfunction
- Date Received
- April 16, 2025
- Date of Event
- October 23, 2024
- Report Date
- May 21, 2025
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- OOI
- UDI-DI
- 00382904439897
- PMA / PMN Number
- SEE H11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B.2: IT WAS REPORTED THAT DURING USE OF THE BD COR¿ MX, 8 SAMPLES WERE FALSE POSITIVE FOR BOTH CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE. AFTER INSPECTING REAGENTS AND INSTRUMENT, A "BLOODY SLIME STRING" FROM A SAMPLE WAS FOUND DRAGGED OVER PROCESS AREA AND CONTAMINATED SAMPLES. CLEANING AND ENVIRONMENTAL TESTING WERE PERFORMED. SAMPLES WERE RERUN AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. D.1: MEDICAL DEVICE BRAND NAME: BD COR¿ MX. D.2A: MEDICAL DEVICE COMMON NAME: THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY. D.2B: MEDICAL DEVICE TYPE: LSL, MKZ, OUY, QEP. D.3: MEDICAL DEVICE MANUFACTURE DATE: 05/26/2022. D.4: MEDICAL DEVICE CATALOG #: 443989. D.4: MEDICAL DEVICE SERIAL #: (B)(6). D.4: MEDICAL DEVICE UDI: (B)(4). G.5: PMA: NA.
INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT HAD "FALSE POSITIVES." CUSTOMER REPORTED THAT THEY ARE WITNESSING SUSPECTED FALSE POSITIVE RESULTS FOR CHLAMYDIA AND GONORRHEA WHILE RUNNING THE CT/GC ASSAY. BD INTERVIEWED THE CUSTOMER ON THE INCIDENT AND THE CUSTOMER CONFIRMED THAT VISIBLE CONTAMINATION EVIDENCE WAS PRESENT AS AN EXTREMELY MUCOIDAL SAMPLE WAS OBSERVED TO HAVE DRIPPED ACROSS MULTIPLE TEST LANES. THE CUSTOMER PERFORMED CLEANING AND ENVIRONMENTAL MONITORING AND WAS ABLE TO RESOLVE THE ISSUE. NO FURTHER INTERVENTION WAS NECESSARY BY BD. THIS COMPLAINT IS UNCONFIRMED AS THE ROOT CAUSE OF THE FAILURE WAS DETERMINED TO BE DUE TO CONTAMINATION BY A PATIENT SAMPLE DURING NORMAL OPERATING CONDITIONS OF THE INSTRUMENT. NO PARTS WERE REPLACED AS PART OF THIS COMPLAINT, AND THEREFORE NO SAMPLES WERE RETURNED AND NO RETURNED MATERIAL INVESTIGATION COULD OCCUR. REVIEW OF THE DEVICE HISTORY RECORD FOR THE INSTRUMENT IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND THE COMPLAINT IS UNCONFIRMED, THUS A DHR REVIEW WOULD YIELD NO USEFUL INFORMATION. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT AND NO ADDITIONAL CASES WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS COMPLAINT. NO NEW RISKS OR HAZARDS, OR CHANGES TO EXISTING RISKS/HAZARDS, WERE IDENTIFIED AS A RESULT OF THIS COMPLAINT.
D.2. ADDITIONAL MEDICAL DEVICE TYPES: NQX, NJR, OZN. G.4. THERE WERE MULTIPLE PMA/510K NUMBERS: K111860, K120138, K130470". A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT DURING USE OF THE BD COR¿ MX, 8 SAMPLES WERE FALSE POSITIVE FOR BOTH CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE. AFTER INSPECTING REAGENTS AND INSTRUMENT, A "BLOODY SLIME STRING" FROM A SAMPLE WAS FOUND DRAGGED OVER PROCESS AREA AND CONTAMINATED SAMPLES. CLEANING AND ENVIRONMENTAL TESTING WERE PERFORMED. SAMPLES WERE RERUN AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, 8 SAMPLES WERE FALSE POSITIVE FOR BOTH CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE. AFTER INSPECTING REAGENTS AND INSTRUMENT, A "BLOODY SLIME STRING" FROM A SAMPLE WAS FOUND DRAGGED OVER PROCESS AREA AND CONTAMINATED SAMPLES. CLEANING AND ENVIRONMENTAL TESTING WERE PERFORMED. SAMPLES WERE RERUN AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, 8 SAMPLES WERE FALSE POSITIVE FOR BOTH CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE. AFTER INSPECTING REAGENTS AND INSTRUMENT, A "BLOODY SLIME STRING" FROM A SAMPLE WAS FOUND DRAGGED OVER PROCESS AREA AND CONTAMINATED SAMPLES. CLEANING AND ENVIRONMENTAL TESTING WERE PERFORMED. SAMPLES WERE RERUN AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 112383 | BD COR¿ MX | THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY | OOI | BECTON, DICKINSON & CO. (SPARKS) | 00382904439897 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |