BD MAX¿ VAGINAL PANEL
Received Apr 1, 2024 · Event occurred Mar 4, 2024
Report 3007420875-2024-00025 · MDR key 19012599
Device
Generic name
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Catalog number
443712
Lot number
3291361
Product problems
- False Positive Result
- Non Reproducible Results
- False Positive Result
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH THE BD MAX¿ VAGINAL PANEL, A SAMPLE WAS POSITIVE FOR BOTH BV GROUP AND C GROUP. UPON REPEAT, ONLY BV CAME BACK POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Additional Manufacturer Narrative
H.6 INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX VAGINAL PANEL KIT (REF. 443712) KIT LOT 3291361 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT DISCREPANT RESULTS ON FOR THE CGROUP TARGET WHEN USING THE BD MAX VAGINAL PANEL KIT LOT 3291361. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX VAGINAL PANEL KIT INDICATED THAT LOT 3291361 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. SCANS OF THE RUNS 5090 (BD MAX CT1699) AND 2566 (BD MAX CT2003) WERE PROVIDED BY THE CUSTOMER AND ANALYZED. SAMPLE IN RUN 5090; POSITION A6 THAT GAVE A CGOUP POSITIVE RESULT WAS REPEATED IN RUN 2566; POSITION B1 AND GAVE A CGOUP NEGATIVE RESULT. ANALYSIS OF THE CURVES FROM THE PDF REPORT REVEALED A LATE AMPLIFICATION IN THE ROX CHANNEL IN BOTTOM POSITION (CGROUP TARGET) FOR THE SAMPLE IN POSITION A6 IN RUN 5090. IN RUN 2566, NO AMPLIFICATION IN THAT CHANNEL WAS OBSERVED FOR THE SAMPLE IN POSITION B1. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX VAGINAL PANEL KIT LOT 3291361. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, A SAMPLE AT THE ASSAY LIMIT OF DETECTION (LOD) COULD EXPLAIN THE CUSTOMER ISSUE. INDEED, A LOW POSITIVE SAMPLE COULD GENERATE VARIABLE RESULTS WHEN REPEATED. 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 APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH THE BD MAX¿ VAGINAL PANEL, A SAMPLE WAS POSITIVE FOR BOTH BV GROUP AND C GROUP. UPON REPEAT, ONLY BV CAME BACK POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Additional Manufacturer Narrative
H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: H6: IMDRF ANNEX A GRID: A090804 - FALSE POSITIVE RESULT (1227) B3: DATE OF EVENT 04-MAR-2024
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH THE BD MAX¿ VAGINAL PANEL, A SAMPLE WAS POSITIVE FOR BOTH BV GROUP AND C GROUP. UPON REPEAT, ONLY BV CAME BACK POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.