BD ONEFLOW PCST

Description of Event or Problem

IT WAS REPORTED WHILE PROCESSING BONE MARROW SAMPLE WITH BD ONEFLOW PCST THERE WERE NO MAKING OF THE CD19, CD56 ANTIBODIES OR CD38. CONFIRMATORY TESTING PERFORMED WITH A NEW REAGENT BOX AND CORRECT ANTIBODY MARKINGS WERE OBSERVED. RESULTS WERE NOT REPORTED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: A BONE MARROW SAMPLE WAS PROCESSED FROM A PATIENT WITH A PREVIOUS DIAGNOSIS OF MYELOMA (THE PATIENT IS RECEIVING DARATUMUMAB TREATMENT), THE SAMPLE WAS PROCESSED WITH THE BULK LYSIS PROTOCOL, WHEN ANALYZING THE RESULTS WE SHOWED THAT THERE IS NO MARKING OF THE CD19, CD56 ANTIBODIES NOR CD38 (DUE TO THE TREATMENT OF THE PATIENT, IT IS UNDERSTANDABLE THAT CD38 IS NOT EXPRESSED, BUT IT IS NOT EXPLICABLE THAT THE OTHER ANTIBODIES ARE NOT MARKED); AFTER ENCOUNTERING THIS SITUATION, WE DECIDED TO RERUN THE SAMPLE WITH TUBES FROM A NEW PCST BOX AND THE ANTIBODY LABELING WAS CORRECT SO WE PRESUME THAT THERE IS A DEFECT / DETERIORATION IN THE REAGENT BOX THAT WAS IN USE. WHAT CONFIRMATORY TESTS WERE CARRIED OUT THAT DETERMINED THAT THE RESULTS WERE ERRONEOUS ?: THE SAME SAMPLE WAS PROCESSED WITH A NEW REAGENT BOX, WHICH HAD NOT BEEN STARTED AND THE RESULTS OBTAINED WERE DIFFERENT FROM THOSE OBTAINED INITIALLY, CORRECT ANTIBODY MARKING IS OBTAINED CD19 AND CD56 IN NORMAL POPULATIONS¿ WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO, THE INITIAL RESULTS WERE NOT ISSUED TO THE TREATING PHYSICIAN, THE RESULT WAS ISSUED AFTER BEING CONFIRMED. ADDITIONALLY, ON 2021-03-30 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE BATCH THAT IDENTIFIED CORRECTLY: THE BATCH WITH WHICH THE SAMPLES WERE PROCESSED CORRECTLY CORRESPONDS TO THE SAME BATCH OF THE REAGENT WITH ERROR, THE DIFFERENCE IS THAT THE TUBE THAT PRESENTED ERRONEOUS RESULTS CORRESPONDS TO THE BOX THAT WAS IN USE, THE OTHER BOX WAS NEW REPORT SHOWING THE ERROR.

Additional Manufacturer Narrative

H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF THE ISSUES IS LIMITED TO 659912-027437591-0949-0301379 ONEFLOW PCST. PROBLEM STATEMENT: CD19 AND CD56 WERE NOT DETECTED ON THE PATIENT SAMPLE ON THE PCST REAGENT COMPLAINT LOT AND WAS DETECTED ON THE NEW LOT. A BONE MARROW SAMPLE WAS PROCESSED FROM A PATIENT WITH A PREVIOUS DIAGNOSIS OF MYELOMA (THE PATIENT IS RECEIVING DARATUMUMAB TREATMENT), THE SAMPLE WAS PROCESSED WITH THE BULK LYSIS PROTOCOL, WHEN ANALYZING THE RESULTS WE SHOWED THAT THERE IS NO MARKING OF THE CD19, CD56 ANTIBODIES NOR CD38 (DUE TO THE TREATMENT OF THE PATIENT, IT IS UNDERSTANDABLE THAT CD38 IS NOT EXPRESSED, BUT IT IS NOT EXPLICABLE THAT THE OTHER ANTIBODIES ARE NOT MARKED); AFTER ENCOUNTERING THIS SITUATION, WE DECIDED TO RERUN THE SAMPLE WITH TUBES FROM A NEW PCST BOX AND THE ANTIBODY LABELING WAS CORRECT SO WE PRESUME THAT THERE IS A DEFECT / DETERIORATION IN THE REAGENT BOX THAT WAS IN USE. MANUFACTURING DEFECT TREND: THERE ARE 0 QN¿S RELATED TO THE REPORTED ISSUE. DATE RANGE (B)(6) 2020 TO (B)(6) 2021. ROOT CAUSE ANALYSIS: BASED ON THE INVESTIGATION RESULT THE ROOT CAUSE WAS NOT DETERMINED. COMPLAINT HISTORY REVIEW: THIS IS ONE REPORTED COMPLAINT INCLUDING THIS COMPLAINT. DATE RANGE FROM (B)(6) 2020 TO (B)(6) 2021. RISK REVIEW EUROFLOW MULTICOLOR PCST/PCD TUBE RISK ANALYSIS FILE (B)(4), REVISION C WAS REVIEWED. HAZARD(S) IDENTIFIED? YES. NO. HAZARD #: 3.2,33. HAZARD: INDIRECT HARM TO PATIENT. HAZARD CAUSE: TOO MANY CELLS STAINED RESULTS IN DIM POPULATIONS REQUIRING RE-STAIN OF DILUTED SPECIMEN. HARMFUL EFFECTS: DELAY OF RESULTS. SEVERITY: 2. PROBABILITY: 2. RISK INDEX: 4. RISK CONTROL: IFU STATE THE RANGE OF CELLS TO STAIN (EFM-PCSTPCD-86). IMPLEMENTATION: BD ONEFLOW PCST IFU, SECTION 9.. EFFECTIVENESS: LABELLING APPROVAL. NEW HAZARD: NONE. MITIGATION(S) SUFFICIENT YES . IF NO (TO ABOVE), WHAT ACTIONS WILL BE TAKEN? A RISK ANALYSIS IS NOT REQUIRED IF THIS IS NOT A SAFETY OR REPORTABLE EVENT. BATCH HISTORY RECORD (BHR) REVIEW: THE FOLLOWING BATCH RECORDS WERE REVIEWED. 659912-0274375 BD ONEFLOW PCST. 91-0970-0118747 S REAGENT. 91-0971-0118753 C REAGENT. THE MATERIALS MET ALL THE MANUFACTURING SPECIFICATION PRIOR TO RELEASE. RETURNED SAMPLE ANALYSIS. THE SAMPLE WAS NOT REQUESTED TO BE RETURNED. TWO FCS FILE WAS PROVIDED BY THE CUSTOMER. THE FILES WERE ACQUIRED ON 3/4/2021AND 3/5/2021. ANALYSIS OF BOTH FILES SHOWED, THE ACQUIRED EVENTS WERE >6 MILLION AND 3 MILLION, RESPECTIVELY, AND ~20% OF TOTAL POPULATION WERE CD45 DIM. THE NORMAL LYMPHOCYTE POPULATION WERE LOW FOR BOTH FILES, HOWEVER (B)(6) 2021 FILE HAD SLIGHTLY MORE AND SHOWED THE CD19+ POPULATION, THAN THE OTHER. RETAIN SAMPLE ANALYSIS: NORMAL PERIPHERAL BLOOD SPECIMENS WERE STAINED WITH RETAIN SAMPLE OF PCST REAGENT USING FIX/PERM STAINING PROCEDURE. CD19+ AND CD19- POPULATION WERE GATED OUT OF THE CD45+ LYMPHOCYTES. THE CD19+ WERE EITHER KAPPA+ OR LAMBDA+ CELLS. C56+ AND CD38+ CELLS WERE ALSO GATED OUT FROM CD19- POPULATIONS. RESULTS OF THE NORMAL SPECIMEN STAINED WITH PCST RETAIN SAMPLE REAGENT DEMONSTRATED THE PRESENCE OF THE POPULATIONS THAT EXPRESSED THE MARKERS IN THE REAGENT COCKTAIL. THEREFORE, BASED ON THE STAINED NORMAL SPECIMEN, THE REAGENT PERFORMED AS DESIGNED. CONCLUSION: BASED ON THE INVESTIGATION RESULT: THE COMPLAINT WAS UNCONFIRMED.

Additional Manufacturer Narrative

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 WHILE PROCESSING BONE MARROW SAMPLE WITH BD ONEFLOW PCST THERE WERE NO MAKING OF THE CD19, CD56 ANTIBODIES OR CD38. CONFIRMATORY TESTING PERFORMED WITH A NEW REAGENT BOX AND CORRECT ANTIBODY MARKINGS WERE OBSERVED. RESULTS WERE NOT REPORTED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: A BONE MARROW SAMPLE WAS PROCESSED FROM A PATIENT WITH A PREVIOUS DIAGNOSIS OF MYELOMA (THE PATIENT IS RECEIVING DARATUMUMAB TREATMENT), THE SAMPLE WAS PROCESSED WITH THE BULK LYSIS PROTOCOL, WHEN ANALYZING THE RESULTS WE SHOWED THAT THERE IS NO MARKING OF THE CD19, CD56 ANTIBODIES NOR CD38 (DUE TO THE TREATMENT OF THE PATIENT, IT IS UNDERSTANDABLE THAT CD38 IS NOT EXPRESSED, BUT IT IS NOT EXPLICABLE THAT THE OTHER ANTIBODIES ARE NOT MARKED); AFTER ENCOUNTERING THIS SITUATION, WE DECIDED TO RERUN THE SAMPLE WITH TUBES FROM A NEW PCST BOX AND THE ANTIBODY LABELING WAS CORRECT SO WE PRESUME THAT THERE IS A DEFECT / DETERIORATION IN THE REAGENT BOX THAT WAS IN USE. WHAT CONFIRMATORY TESTS WERE CARRIED OUT THAT DETERMINED THAT THE RESULTS WERE ERRONEOUS ?: THE SAME SAMPLE WAS PROCESSED WITH A NEW REAGENT BOX, WHICH HAD NOT BEEN STARTED AND THE RESULTS OBTAINED WERE DIFFERENT FROM THOSE OBTAINED INITIALLY, CORRECT ANTIBODY MARKING IS OBTAINED CD19 AND CD56 IN NORMAL POPULATIONS¿ WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO, THE INITIAL RESULTS WERE NOT ISSUED TO THE TREATING PHYSICIAN, THE RESULT WAS ISSUED AFTER BEING CONFIRMED. ADDITIONALLY, ON 2021-03-30 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE BATCH THAT IDENTIFIED CORRECTLY: THE BATCH WITH WHICH THE SAMPLES WERE PROCESSED CORRECTLY CORRESPONDS TO THE SAME BATCH OF THE REAGENT WITH ERROR, THE DIFFERENCE IS THAT THE TUBE THAT PRESENTED ERRONEOUS RESULTS CORRESPONDS TO THE BOX THAT WAS IN USE, THE OTHER BOX WAS NEW REPORT SHOWING THE ERROR.