BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM
Report
- Report Number
- 3007420875-2024-00091
- Event Type
- Malfunction
- Date Received
- September 26, 2024
- Date of Event
- August 27, 2024
- Report Date
- December 20, 2024
- 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
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D2: ADDITIONAL MEDICAL DEVICE TYPES: QQX. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ RESPIRATORY VIRAL PANEL ASSAY (REF. 445215) FROM LOT: 3353169 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA, REVIEW OF CUSTOMER¿S PICTURES, RETAIN MATERIAL TESTING AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER REPORTED OBTAINING 2 RSV AND 1 COVID POSITIVE RESULTS WHEN USING AG RAPID TESTS THAT REPEATED NEGATIVE WHEN USING THE BD MAX¿ RESPIRATORY VIRAL PANEL KIT LOT: 3353169. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ RESPIRATORY VIRAL PANEL ASSAY INDICATED THAT LOT: 3353169 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED DATABASE FROM BD MAX INSTRUMENT CT0448 AND PICTURES OF THREE AG RAPID TESTS FOR INVESTIGATION. SINCE NO ADDITIONAL INFORMATION WAS PROVIDED TO HELP IDENTIFY DISCREPANT SAMPLES, BD CANNOT CONFIRM WHICH SAMPLES ARE INVOLVED IN THE ISSUE. HOWEVER, DATABASE ANALYSIS SHOWS THAT THERE ARE ONLY TWO SAMPLES THAT WERE REPEATED AND OBTAINED NEGATIVE RESULTS FOR ALL TARGETS, IN BOTH THE INITIAL AND REPEAT TESTS (RUN 2242; POSITIONS A2 AND A3, AND 2243; A5 AND A6) HENCE THEY WERE SUSPECTED TO BE THE DISCREPANT ONES. IN BOTH SAMPLES, NO AMPLIFICATION WAS VISIBLE FOR ANY TARGET EXCEPT FOR THE INTERNAL CONTROL, AS EXPECTED FOR A NEGATIVE SAMPLE. A POSITIVE RESULT FOR THE AG RAPID TESTS MEANS THAT THE PATIENT WAS PREVIOUSLY INFECTED WITH THE VIRUS, DEVELOPED ANTIGENS AGAINST THE VIRUS BUT IT IS POSSIBLE THAT THERE ARE NO REMAINING VIRAL PARTICLES IN THE PATIENT. AS PER THE INSTRUCTION FOR USE (IFU) DOCUMENT, THE INTENDED USE OF THE BD MAX¿ RESPIRATORY VIRAL PANEL IS FOR PATIENTS DISPLAYING SYMPTOMS OF A RESPIRATORY VIRAL INFECTION. THE RETAIN MATERIAL OF BD MAX¿ RESPIRATORY VIRAL PANEL FROM LOT: 3353169 WAS TESTED AND THE RESULTS WERE AS EXPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE BD MAX¿ RESPIRATORY VIRAL PANEL ASSAY LOT: 3353169. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION SINCE NO NEW HAZARD OR TRENDS WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.
REPORT 1 OF 3: IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ RESPIRATORY VIRAL PANEL, A FALSE NEGATIVE RSV PATIENT RESULT WAS OBTAINED. THE CUSTOMER RE-RAN SAMPLE ON RSV RAPID TEST AND RESULT WAS POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
REPORT 1 OF 3: IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ RESPIRATORY VIRAL PANEL, A FALSE NEGATIVE RSV PATIENT RESULT WAS OBTAINED. THE CUSTOMER RE-RAN SAMPLE ON RSV RAPID TEST AND RESULT WAS POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1371800 | 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) | 3353169 | 00382904452155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |