BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM
Received Feb 20, 2025 · Event occurred Jan 23, 2025
Report 3007420875-2025-00038 · MDR key 21424059
Device
Generic name
Multiple-genus Respiratory Virus Nucleic Acid Ivd, Kit, Nucleic Acid Technique
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Catalog number
445215
Lot number
4323150
Product problems
- False Positive Result
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM 445215 LOT 4323158 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, 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 4323158 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT A COVID POSITIVE RESULT (COV-2 POSITIVE RESULT) OBTAINED WITH THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM KIT LOT 4323158 WHICH WAS NOT REPRODUCED WITH THE BD SARS COV-2 REAGENTS FOR BD MAX¿ SYSTEMS ASSAY. CUSTOMER PROVIDED THE DATABASE FROM BD MAX¿ INSTRUMENT CT3385 FOR THE INVESTIGATION. THE PROBLEMATIC SAMPLE WAS INITIALLY TESTED WITH THE BD SARS COV-2 REAGENTS FOR BD MAX¿ SYSTEMS ASSAY IN RUN 556 (POSITION A11) AND GAVE COV-2, N1 AND N2 NEGATIVE RESULTS. THE PATIENT SAMPLE WAS TESTED ONCE MORE USING THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM KIT LOT 4323158 IN RUN 557 (POSITION A2) AND GAVE A COV-2 POSITIVE RESULT. MANUAL PCR CURVE ADJUDICATION OF THE COV-2 TARGETS IN THE DISCREPANT SAMPLES REVEALED A LATE AND LOW, BUT TRUE AMPLIFICATION, GENERATED A POSITIVE RESULT FOR THE COV2 TARGET WITH THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM ASSAY, WITHOUT ANY ANOMALY. MOREOVER, NO ANOMALY WAS OBSERVED IN THE INITIAL TEST DONE WITH THE BD SARS COV-2 REAGENTS FOR BD MAX¿ SYSTEMS ASSAY, WITH FLAT CURVES AND NO AMPLIFICATION OF ANY TARGET RESULTING IN THE COV2, N1 AND N2 TARGETS NEGATIVE RESULT. 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 4323158. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, A SPECIMEN AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION, ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS IN THE REPEAT TEST WITH THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM ASSAY. 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.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, A FALSE POSITIVE SARS-COV-2 PATIENT RESULT WAS OBTAINED. SAMPLE WAS RETESTED USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM AND WAS NEGATIVE FOR SARS-COV-2. THERE WAS NO REPORT OF PATIENT IMPACT.
Additional Manufacturer Narrative
D.2. 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.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, A FALSE POSITIVE SARS-COV-2 PATIENT RESULT WAS OBTAINED. SAMPLE WAS RETESTED USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM AND WAS NEGATIVE FOR SARS-COV-2. THERE WAS NO REPORT OF PATIENT IMPACT.