BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD
Received Mar 8, 2024 · Event occurred Jan 17, 2024
Report 2916837-2024-00020 · MDR key 18870179
Device
Generic name
Flow Cytometric Reagents And Access
Manufacturer
Becton Dickinson And Company Bd BiosciencesCatalog number
663029
Lot number
NA
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
G.5. THE EVENT DESCRIBED OCCURRED ON AN CE-IVD INSTRUMENT, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED IVD VERSION OF THE INSTRUMENT. THE IVD INSTRUMENT¿S 510K HAS BEEN REPORTED. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER OBSERVES SURRESTIMATION OF ABSOLUTE COUNTING ON ITS BD FACSLYRIC ON FACSUITE CLINICAL SOFTWARE AS COMPARED WITH NUMERATION ON ITS SYSMEX HEMATOCYTOMETER THE USER IS ABLE TO GENERATE ABSOLUTE COUNTING WITH TWO DIFFERENT METHODS. BD METHOD AND SYSMEX METHOD. THERE IS A GAP IN TERMS OF ABSOLUTE COUNTING RESULTS BETWEEN THE TWO PLATFORMS. WE DON¿T KNOW WHICH SYSTEM IS CURRENTLY PROVIDING THE CORRECT RESULTS.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: D.4. MEDICAL DEVICE SERIAL #: (B)(6). D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H.4. DEVICE MANUFACTURE DATE: 12-JUN-2019. H.6 IMDRF ANNEX B: B21. H.6 IMDRF ANNEX C: C21. H.6 IMDRF ANNEX D: D16.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER OBSERVES SURRESTIMATION OF ABSOLUTE COUNTING ON ITS BD FACSLYRIC ON FACSUITE CLINICAL SOFTWARE AS COMPARED WITH NUMERATION ON ITS SYSMEX HEMATOCYTOMETER THE USER IS ABLE TO GENERATE ABSOLUTE COUNTING WITH TWO DIFFERENT METHODS. BD METHOD AND SYSMEX METHOD. THERE IS A GAP IN TERMS OF ABSOLUTE COUNTING RESULTS BETWEEN THE TWO PLATFORMS. WE DON¿T KNOW WHICH SYSTEM IS CURRENTLY PROVIDING THE CORRECT RESULTS.
Additional Manufacturer Narrative
AFTER FURTHER INVESTIGATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. THE INCIDENT IS A REPORTABLE MALFUNCTION, HOWEVER THE INVESTIGATION DETERMINED THAT THE CAUSE WAS NOT THE INSTRUMENT. MFR REPORTS 2647876-2024-00044 AND 2647876-2024-00045 WERE REPORTED FOR ERRONEOUS RESULTS ON TWO DIFFERENT REAGENT BATCH NUMBERS THAT WERE RUN ON THIS INSTRUMENT.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER OBSERVES SURRESTIMATION OF ABSOLUTE COUNTING ON ITS BD FACSLYRIC ON FACSUITE CLINICAL SOFTWARE AS COMPARED WITH NUMERATION ON ITS SYSMEX HEMATOCYTOMETER THE USER IS ABLE TO GENERATE ABSOLUTE COUNTING WITH TWO DIFFERENT METHODS. BD METHOD AND SYSMEX METHOD. THERE IS A GAP IN TERMS OF ABSOLUTE COUNTING RESULTS BETWEEN THE TWO PLATFORMS. WE DON¿T KNOW WHICH SYSTEM IS CURRENTLY PROVIDING THE CORRECT RESULTS.