BD ONEFLOW ALOT

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS NEGATIVE SMCD3 RESULTS OCCURRED WITH A BD ONEFLOW¿ ALOT. RESULTS WERE NOT USED TO DIAGNOSE PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HEMATO PATHOLOGIST OF IS QUESTIONING ON THE PERFORMANCE OF ONEFLOW A LOT TUBE. THE POI IS CD19+/ CD20+ WHICH THE ONEFLOW ALOT TUBE SHOWING SMCD3+ BUT LST TUBE SHOWED SMCD3 IS NEGATIVE. ADDITIONALLY, ON 2020-8-13 THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: YES. THIS IS ERRONEOUS RESULT BUT IT DOES NOT AFFECT THE PATIENT DIAGNOSIS. THIS SAMPLE WERE INTENDED FOR CLINICAL USE.

Additional Manufacturer Narrative

H.6. INVESTIGATION: PROBLEM STATEMENT: THE POI (POPULATION OF INTEREST) WAS CD19+ WHEN STAINED WITH ONEFLOW ALOT TUBE, AND ALSO WAS SMCD3+ POSITIVE. THE CUSTOMER THOUGHT THE SMCD3+ RESULT OF THE ALOT REAGENT WAS INCORRECT. THEY CONFIRMED WITH LST, AND THE RESULT FOR SMCD3 WAS NEGATIVE. MANUFACTURING DEFECT TREND: FROM 08/10/2019 TO 08/10/2020, NO QN WAS GENERATED IN SAP FOR THE FOLLOWING MATERIALS: 91-0996-9319811 POUCH ONEFLOW ALOT-S. 60-0799-9310197 RGNT ONEFLOW ALOT-S. 91-1006-9322750 POUCH ONEFLOW ALOT-C. 60-0811-9311205 RGNT ONEFLOW ALOT C. COMPLAINT TREND: ANOTHER PIR COMPLAINT WAS REPORTED FOR CATALOG# 660228 FROM 10AUG2019 TO 10AUG2020. BATCH HISTORY RECORD REVIEW: REVIEW THE PRODUCTION BATCH RECORDS FOR MATERIAL 660288-0036701 AND THE FOLLOWING IN-PROCESS MATERIALS THAT WAS PART OF THE ALOT KIT. 91-0996- 9319811 POUCH ONEFLOW ALOT-S. 60-0799-9310197 RGNT ONEFLOW ALOT-S. 91-1006-9322750 POUCH ONEFLOW ALOT-C. 60-0811-9311205 RGNT ONEFLOW ALOT C. ALL BATCH RECORDS REVIEWED PASSED ALL THE ACCEPTANCE CRITERIA IN PLACE, TO RELEASE THE PRODUCT TO INVENTORY. RESULT OF RETAIN SAMPLE TESTING: RETAIN SAMPLE WAS USED TO STAIN PERIPHERAL BLOOD SPECIMEN FROM A NORMAL DONOR. STAINING PROCEDURE FOLLOWED THE FIX/PERM METHOD AND ACQUIRED IN A BD CYTOMETER. FCS FILE WAS ANALYZED IN A DIVA SOFTWARE. ANALYSIS OF THE DATA DEMONSTRATED THAT THE CD19 PE-CY7 AND SMCD3 APC-H7 ANTIBODIES IN THE ALOT REAGENT RECOGNIZED THE B CELL AND THE T CELL SUBSETS IN THE LYMPHOCYTE POPULATION, RESPECTIVELY. NO. CD13+CD19+ POPULATION WAS OBSERVED IN THE STAINED SAMPLE. PLEASE SEE THE PPP DOCUMENT ENTITLED PIR# (B)(4) INVESTIGATION. RESULT OF RETURNED SAMPLE EVALUATION: NO TASK WAS CREATED FOR THE RETURN OF THE SAMPLE. RETAIN TESTING OF THE REAGENT WAS CONDUCTED FOR PERFORMANCE EVALUATION OF THE PRODUCT. THE PHOTO SUBMITTED BY THE CUSTOMER WAS USED TO UNDERSTAND THE CUSTOMER COMPLAINT. INVESTIGATION RESULT / ANALYSIS: BASED ON THE REVIEW OF THE PHOTO SUBMITTED BY THE CUSTOMER IN THE COMPLAINT AND THE RESULT OF THE RETAIN SAMPLE TESTING CONDUCTED IN HOUSE, IT WAS DETERMINED THAT THE CUSTOMER COMPLAINT WAS NOT DUPLICATED WITH THE RETAIN SAMPLE TESTING USING A NORMAL SPECIMEN. THEREFORE, THE COMPLAINT WAS UNCONFIRMED. RISK ANALYSIS: REVIEWED RISK ANALYSIS DOCUMENT: SAP#: (B)(4) REVB, BD ONEFLOW ALOT RISK ANALYSIS HAZARD(S) IDENTIFIED? YES. HAZARD #: 3.2 USE ERRORS. ID 3.2.3; HAZARD: INDIRECT HARM TO PATIENT. CAUSE: BLOOD/BONE MARROW EXCEEDS THE RECOMMENDED AGE OF SPECIMEN REQUIREMENT (24 HOUR AGE OF SPECIMEN). HARMFUL EFFECT: INCORRECT RESULTS. PROBABILITY: 2; SEVERITY: 2; RISK INDEX: 4; INITIAL RISK EVALUATION: ACCEPTABLE. RISK CONTROL: IFU TO STATE AGE OF SPECIMEN TO BE WITHIN THE RECOMMENDED AGE OF SPECIMEN TIMEFRAME. (EFM-DID-13709 AND EFM-DID-13710) IMPLEMENTATION VERIFICATION: BD ONEFLOW A LOT IFU, SECTION 8, SPECIMEN. HAZARD #: 3.2 USE ERRORS: ID 3.2.10; HAZARD: INDIRECT HARM TO PATIENT. CAUSE: IMPROPER STORAGE OF SPECIMENS PRIOR TO STAINING (OUTSIDE OF ENVIRONMENTAL CONDITIONS. HARMFUL EFFECT: INCORRECT RESULTS; PROBABILITY: 3; SEVERITY: 2; RISK INDEX: 6; INITIAL RISK EVALUATION: UNACCEPTABLE; RISK CONTROL: IFU TO STATE LIMITATION OF AGE OF SPECIMEN PER REQUIREMENT (EFM-DID-13709 AND EFM-DID-13710); IMPLEMENTATION VERIFICATION: BD ONEFLOW A LOT IFU, SECTION 8, SPECIMEN. MITIGATION(S) SUFFICIENT: YES. INVESTIGATION CONCLUSION: RESULTS OF THE HISTORICAL BATCH RECORD INVESTIGATION SHOWED THAT THE PRODUCT COMPLIED AND PASSED ALL QC SPECIFICATIONS. RESULT OF RETAIN INVESTIGATION TEST, DID NOT CONFIRM THE CUSTOMER COMPLAINT. THE CD19 PE-CY7 AND SMCD3 APC-H7 ANTIBODIES IN THE ALOT REAGENT RECOGNIZED THE B CELL AND THE T CELL SUBSETS IN THE LYMPHOCYTE POPULATION, RESPECTIVELY, WHEN USED TO STAIN A PERIPHERAL BLOOD SPECIMEN COMING FROM A NORMAL SUBJECT. NO CD3+CD19+ POPULATION WAS OBSERVED ON THE STAINED SAMPLE.

Additional Manufacturer Narrative

A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS NEGATIVE SMCD3 RESULTS OCCURRED WITH A BD ONEFLOW¿ ALOT. RESULTS WERE NOT USED TO DIAGNOSE PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HEMATO PATHOLOGIST OF IS QUESTIONING ON THE PERFORMANCE OF ONEFLOW A LOT TUBE. THE POI IS CD19+/ CD20+ WHICH THE ONEFLOW ALOT TUBE SHOWING SMCD3+ BUT LST TUBE SHOWED SMCD3 IS NEGATIVE. ADDITIONALLY, ON 2020-8-13 THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: YES. THIS IS ERRONEOUS RESULT BUT IT DOESN'T AFFECT THE PATIENT DIAGNOSIS. THIS SAMPLE WERE INTENDED FOR CLINICAL USE.