BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM
Report
- Report Number
- 3007420875-2025-00037
- Event Type
- Malfunction
- Date Received
- February 20, 2025
- Date of Event
- January 24, 2025
- Report Date
- May 23, 2025
- Manufacturer
- GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
- Product Code
- QOF
- UDI-DI
- 00382904452155
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM (REF. (B)(4)) LOT 4250956 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM INDICATED THAT LOT 4250956 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE RETAIN MATERIAL OF BD RESPIRATORY VIRAL PANEL KIT FOR BD MAX¿ SYSTEM FROM LOT 4250956 WAS TESTED AND THE RESULTS WERE AS EXPECTED. CUSTOMER COMPLAINED ABOUT A PATIENT SAMPLE THAT GAVE A FLUB NEGATIVE RESULT IN THE INITIAL TEST (RUN 5342, POSITION A3) BUT WAS POSITIVE ON THE RETEST (RUN 5345), WHEN USING THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM KIT LOT 4250956. CUSTOMER PROVIDED THE TWO RUN FILES (RUNS 5342 AND 5345) FROM BD MAX¿ INSTRUMENT CT2309 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION OF BOTH RUNS WAS PERFORMED. THE RETEST WAS DONE USING ANOTHER SAMPLE PREPARATION AND GAVE A FLUB POSITIVE RESULT WITHOUT ANOMALY. ANALYSIS OF THE PCR CURVE FOR SAMPLE A3 IN RUN 5342 SHOWS A LATE AND LOW AMPLIFICATION FOR CY5.5 CHANNEL (FLUB TARGET). THE AMPLIFICATION CURVE DID NOT MEET THE THRESHOLD REQUIRED TO BE FLUB POSITIVE. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM LOT 4250956. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, SAMPLE AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) IS THE MOST LIKELY CAUSE TO EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED AT THIS TIME SINCE NO NEW HAZARD WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD LIFE SCIENCES QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.
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 RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, A FALSE NEGATIVE FLU B PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED ON ID NOW INFLUENZA A & B KIT IN PRESENCE OF CLINICAL SIGNS, AND WAS FLU B POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
IT WAS REPORTED THAT DURING USE OF THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, A FALSE NEGATIVE FLU B PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED ON ID NOW INFLUENZA A & B KIT IN PRESENCE OF CLINICAL SIGNS, AND WAS FLU B POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 465549 | BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM | MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD, KIT, NUCLEIC ACID TECHNIQUE | QOF | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) | 4250956 | 00382904452155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |