BD MAX¿ ENTERIC VIRAL PANEL
Report
- Report Number
- 3007420875-2025-00059
- Event Type
- Malfunction
- Date Received
- March 27, 2025
- Date of Event
- February 24, 2025
- Report Date
- June 4, 2025
- Manufacturer
- GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
- Product Code
- OOI
- UDI-DI
- 00382904439859
- PMA / PMN Number
- K220607
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D.2. ADDITIONAL MEDICAL DEVICE TYPE: PCH. E.1. INITIAL REPORTER PHONE NUMBER: (B)(6). 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¿ ENTERIC VIRAL PANEL (REF. (B)(4)) LOTS 4233917 AND 4233920 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX¿ ENTERIC VIRAL PANEL (EVP) INDICATED THAT THE LOTS 4233917 AND 4233920 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT THREE OCCURRENCES OF SUSPECTED FALSE POSITIVE RESULTS OBTAINED WITH TWO EVP KIT LOT 4233917 (RUNS 1818 AND 1824) AND ONE WITH LOT 4233920 (RUN 1814). CUSTOMER PROVIDED A RESULT REPORT, A WORD DOCUMENT WITH THE DISCREPANT DETAILS AND THE DATABASE OF BD MAX¿ INSTRUMENT CT1861 FOR INVESTIGATION. THE FIRST DISCREPANT SAMPLE B2 IN RUN 1814 OBTAINED POSITIVE RESULT FOR NOV AND HASTV TARGETS IN THE INITIAL TEST. THE RETEST (RUN 1817, POSITION B3) CONFIRMED ONLY THE NOV POSITIVE RESULT, USING A NEW SAMPLE PREPARATION. MANUAL PCR CURVES ADJUDICATION OF THE AMPLIFICATION CURVES IN THE INITIAL TEST, REVEALED A LATE AND LOW AMPLIFICATION FOR HASTV TARGET (ROX CHANNEL BOTTOM POSITION), APPEARING AS A TRUE POSITIVE HASTV RESULT. THE PCR CURVES IN THE RETEST (RUN 1817, POSITION B3) ALSO SHOWED AMPLIFICATION, BUT IT WAS LOWER THAN THE INITIAL TEST AND DID NOT PASS THE THRESHOLDS TO BE HASTV POSITIVE. SAMPLE AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION, ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS FOR THE HASTV TARGET. AMPLIFICATION CURVES FOR THE NOV TARGET (ROX CHANNEL, TOP POSITION) WERE AS EXPECTED, SHOWING STRONG POSITIVE RESULTS WITHOUT ANOMALY, IN BOTH INITIAL AND REPEAT TEST. THE SECOND DISCREPANT SAMPLE WAS HASTV POSITIVE WHEN FIRST TESTED IN RUN 1818, POSITION A9, THE RETEST IN RUN 1819, POSITION A8 WAS NEGATIVE USING A NEW SAMPLE PREPARATION. ANALYSIS OF THE PCR CURVE IN THE INITIAL TEST SHOWS A STEP DISLOCATION IN THE RAW PCR SIGNAL AND GENERATED POSITIVE RESULTS FOR THE HASTV TARGET. IT IS UNLIKELY THAT THE STEP DISLOCATIONS ARE DUE TO TRUE AMPLIFICATION. THE RETEST SHOWED NO AMPLIFICATION NOR ANOMALY. UNFORTUNATELY, NO ROOT CAUSE COULD BE IDENTIFIED FOR THE POSITIVE RESULT IN THE INITIAL TEST. THE LAST DISCREPANT SAMPLE WAS INITIALLY TESTED IN RUN 1824, POSITION A10 AND WAS FOUND SAV (VIC BOT) AND HASTV (ROX BOT) POSITIVE INITIALLY. THE RETEST WAS NEGATIVE FOR ALL TARGETS USING A NEW SAMPLE PREPARATION. ANALYSIS OF THE PCR CURVE IN THE INITIAL TEST SHOWS A STEP DISLOCATION IN THE RAW PCR SIGNAL AND GENERATED POSITIVE RESULTS FOR HASTV AND SAV TARGETS. IT IS UNLIKELY THESE POSITIVE RESULTS ARE TRUE AMPLIFICATION. THE RETEST SHOWED NO AMPLIFICATION NOR ANOMALY. UNFORTUNATELY, NO ROOT CAUSE COULD BE IDENTIFIED FOR THE POSITIVE RESULTS IN THE INITIAL TEST. OVERALL, SAMPLES AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION, ARE THE MOST LIKELY CAUSES TO EXPLAIN THE DISCREPANT RESULT IN RUN 1814 WHEREAS STEP DISLOCATIONS DUE TO UNEXPECTED EVENTS ARE RESPONSIBLE FOR THE TWO OTHER DISCREPANT RESULTS (RUNS 1818 AND 1824). ALTHOUGH BD IS UNABLE TO IDENTIFY THE CAUSE FOR THESE STEP DISLOCATIONS, NO REAGENTS ISSUE IS SUSPECTED OF BEING INVOLVED IN THE ISSUE. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX ENTERIC VIRAL PANEL LOTS 4233917 AND 4233920. 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 (CAPA) SINCE NO NEW HAZARD WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.
REPORT 2 OF 3: IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ ENTERIC VIRAL PANEL, A SPECIMEN WAS FALSE POSITIVE FOR ASTROVIRUS. SPECIMEN WAS REPEATED AND WAS ASTROVIRUS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
REPORT 2 OF 3: IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ ENTERIC VIRAL PANEL, A SPECIMEN WAS FALSE POSITIVE FOR ASTROVIRUS. SPECIMEN WAS REPEATED AND WAS ASTROVIRUS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2472012 | BD MAX¿ ENTERIC VIRAL PANEL | GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM | OOI | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) | 4233917 | 00382904439859 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |