BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM

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 4 OF 5: IT WAS REPORTED THAT DURING USE OF THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, A FLU A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WERE REPEATED ON CEPHEID GENEXPERT AND WERE 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. THE ROOT CAUSE FOR THE CY5 SIGNAL DRIFT ISSUE 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.

Description of Event or Problem

REPORT 4 OF 5: IT WAS REPORTED THAT DURING USE OF THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, A FLU A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WERE REPEATED ON CEPHEID GENEXPERT AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.