BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM
Received Oct 31, 2024 · Event occurred Oct 2, 2024
Report 3007420875-2024-00108 · MDR key 20577282
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
4194293
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
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
REPORT 3 OF 4: IT WAS REPORTED THAT DURING USE OF THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. WHEN THE SAMPLE WAS REPEATED, THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Description of Event or Problem
REPORT 3 OF 4: IT WAS REPORTED THAT DURING USE OF THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. WHEN THE SAMPLE WAS REPEATED, THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY : THERE IS AN INDICATION OF A BD PCR CARTRIDGES (REF. (B)(4)) ISSUE FOR THE LOT USED BY THE CUSTOMER BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR UNUSUAL CURVES PRESENTING AN UPWARD DRIFT IN THE CY5 CHANNEL WHEN USING THE BD PCR CARTRIDGES WITH THE BD MAX RVP ASSAY. ALTHOUGH THIS UPWARD DRIFT EXPLAINS THE POSITIVE AND VALID NEGATIVE RESULTS OBTAINED FOR THESE SAMPLES, THE CURVES DO NOT SUGGEST TRUE AMPLIFICATIONS. CARTRIDGES MAY CONTRIBUTE TO FLU A FALSE POSITIVE RESULTS (CY5 CHANNEL) AND NEGATIVE CONTROL FAILURE (RNASEP VALID RESULT; ROX CHANNEL), DUE TO BACKGROUND CORRECTION VARIABILITY. THE ROOT CAUSE FOR THE CY5 AND ROX CHANNEL FLUORESCENCE SIGNAL ISSUES ASSOCIATED WITH THE BD PCR CARTRIDGES LOT WAS IDENTIFIED DURING CORRECTIVE AND PREVENTIVE ACTION INVESTIGATION. A CHANGE IN THE ADHESIVE SUPPLIER BY BD¿S PCR CARTRIDGE LABEL SUPPLIERS WAS IDENTIFIED AS THE ROOT CAUSE FOR THE OBSERVED ISSUE. ACTIONS WERE TAKEN BOTH INTERNALLY AT BD AND EXTERNALLY WITH OUR SUPPLIERS TO PREVENT THE RECURRENCE OF THIS PRODUCT ISSUE. BD CONFIRMS THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.