BD FACSPRESTO INSTRUMENT

Additional Manufacturer Narrative

AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION MFR#2916837-2021-00420 HAS BEEN DETERMINED TO BE NOT REPORTABLE. THE INSTRUMENT WAS UNABLE TO DETECT THE CARTRIDGE. THIS PARTICULAR EVENT IS LIKELY TO BE ASSOCIATED WITH A SHORT-TERM INTERRUPTION IN THE DEVICES ABILITY TO PERFORM AS INTENDED, A CLINICALLY INCONSEQUENTIAL PROLONGATION IN DIAGNOSTIC IDENTIFICATION. THIS WOULD REQUIRE THE USER TO ACQUIRE ANOTHER COMPONENT TO BE USED IN ORDER TO USE INSTRUMENT AS INTENDED. THIS IS UNLIKELY TO CAUSE SERIOUS INJURY. AS A RESULT MFR#2916837-2021-00420 IS NULL AND VOID.

Description of Event or Problem

IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS WHILE USING BD FACSPRESTO INSTRUMENT. THESE ARE RELATED TO IVD INSTRUMENT HARDWARE, IVD/ASR REAGENT, AND RUO LDT REAGENT. IT IS UNCLEAR WHETHER THE ERRONEOUS RESULTS WERE CAUSED FROM AN RUO REAGENT, OR A COMBINATION OF IVD OR RUO REAGENTS, OR THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN " (B)(4) ", IT HAS BEEN MENTIONED AS " POOR SAMPLE DISPERSION IN CARTRIDGE" AS A PART OF COMPLIANCE REVIEW, COULD YOU PLEASE ANSWER THE FOLLOWING QUESTIONS? ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? NO. WHAT IS THE CURRENT MEDICAL STATUS? NO.

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED MULTICOLOR FLUORESCENT IMAGING CYTOMETRIC ANALYSIS SYSTEM. MEDICAL DEVICE EXPIRATION DATE: NA. 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 THERE WERE ERRONEOUS RESULTS WHILE USING BD FACSPRESTO INSTRUMENT. THESE ARE RELATED TO IVD INSTRUMENT HARDWARE, IVD/ASR REAGENT, AND RUO LDT REAGENT. IT IS UNCLEAR WHETHER THE ERRONEOUS RESULTS WERE CAUSED FROM AN RUO REAGENT, OR A COMBINATION OF IVD OR RUO REAGENTS, OR THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN "(B)(4)", IT HAS BEEN MENTIONED AS "POOR SAMPLE DISPERSION IN CARTRIDGE". AS A PART OF COMPLIANCE REVIEW, COULD YOU PLEASE ANSWER THE FOLLOWING QUESTIONS? ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? NO. WHAT IS THE CURRENT MEDICAL STATUS? NO.