BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM
Received Nov 6, 2024 · Event occurred Oct 11, 2024
Report 3007420875-2024-00117 · MDR key 20620290
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
D2: ADDITIONAL MEDICAL DEVICE TYPES: QQX. E1: 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.
Description of Event or Problem
REPORT 4 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. THERE WAS NO REPORT OF PATIENT IMPACT.
Description of Event or Problem
REPORT 4 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.
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. THE ROOT CAUSE FOR THE CY5 SIGNAL DRIFT ISSUE ASSOCIATED WITH THE BD PCR CARTRIDGES LOT WAS NOT IDENTIFIED BUT A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO IDENTIFY ROOT CAUSE. ALTHOUGH THE ISSUE WAS NOT REPRODUCED WHEN TESTING RETAIN CARTRIDGE MATERIAL, BD CONFIRMS THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.