IT WAS REPORTED THAT WHILE USING BD CD38 PE-CY7 CE REAGENT. "WEAK FLUORESCENT SIGNAL COMPARED TO PREVIOUS BATCHES (1 LOG OF DIFFERENCE) 3 UNITS OF SAME LOT". TYPE OF PATIENT IMPACT IF ANY IS UNKNOWN AT THIS TIME. DID THIS RESULT IN ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? YES. IF YES, PLEASE PROCEED TO QUESTION #2. IF NO, NO FURTHER QUESTIONS ARE NECESSARY. WAS AN ERRONEOUS LABORATORY RESULT FROM THE BDB PRODUCT REPORTED TO A CLINICIAN? YES. IF YES, PLEASE PROCEED TO QUESTION #3. IF NO, NO FURTHER QUESTIONS ARE NECESSARY. WAS THERE A CHANGE OR DELAY IN TREATMENT DUE TO THIS ISSUE? DON'T KNOW. IF YES, PLEASE PROCEED TO QUESTION #4. IF NO, PLEASE PROCEED TO QUESTION #5. PLEASE DESCRIBE ANY ADDITIONAL DETAILS. PROCEED TO QUESTION #5. DON'T KNOW. DID THIS ISSUE RESULT IN PHYSICAL DAMAGE/INJURY OR NEGATIVE REPERCUSSIONS FOR THE PATIENT? IF YES, PROCEED TO QUESTION #6. IF NO, NO FURTHER QUESTIONS ARE NECESSARY. DON'T KNOW. PLEASE PROVIDE DETAILS: HOW AND TO WHAT EXTENT? PROCEED TO QUESTION 7. DON'T KNOW. WHAT IS THE CURRENT STATE OF HEALTH? DON'T KNOW.
N
Patient 0
G.5. THE EVENT DESCRIBED OCCURRED ON A CE IVD MARKED REAGENT. HOWEVER, IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED ASR REAGENT (335808). THE US REAGENT 510K (EXEMPT) HAS BEEN REPORTED. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
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Patient 0
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: D.3. MEDICAL DEVICE MANUFACTURER: BD CARIBE LTD. ? CAYEY, PR / 00737. D.4. MEDICAL DEVICE CATALOG #: 335825. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: BD CARIBE LTD. ? CAYEY, PR / 00737. H.4. DEVICE MANUFACTURE DATE: 06MAR2025. H.6 INVESTIGATION SUMMAY: ? BASED ON THE INVESTIGATION RESULTS, LOT-TO-LOT WEAK FLUORESCENCE SIGNAL VARIABILITY COMPLAINT AGAINST PRODUCT CATALOG 335825 (CD38 PE-CY7, CLONE HB7, CE-IVD) LOT 5065879 WAS CONFIRMED BASED ON THE DATA PROVIDED, HOWEVER, THE INVESTIGATION FOUND THIS PRODUCT PERFORM AS INTENDED AND NO DISCREPANCY OBSERVED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: ? CUSTOMER PROVIDED FLOW CYTOMETRY DATA WAS EVALUATED. ? FLOW CYTOMETRY TESTING PERFORMED ON THE RETENTION SAMPLE, IN WHICH THE RESULTS SHOW EXPECTED POSITIVE SIGNAL FOR CD38 MARKER, AS PER PRODUCT IFU 23-5091 REV 07 REPRESENTATIVE DATA. ? BATCH HISTORY RECORD (BHR) EVALUATION, WHICH FOUND NO DISCREPANCY, NONCONFORMANCE OR PROCESS DEVIATIONS. ? THE POTENTIAL CAUSE CANNOT BE DETERMINED, AS PRODUCT PERFORMS AS INTENDED AND THERE IS NO LOT-TO-LOT PERFORMANCE VARIABILITY CLAIMS FOR THIS PRODUCT. ? FOR RESOLUTION, CUSTOMER WAS PROVIDED WITH A REPLACEMENT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE DATA COLLECTED FOR IDENTIFICATION OF EMERGING TRENDS.
D
Patient 0
IT WAS REPORTED THAT WHILE USING BD CD38 PE-CY7 CE REAGENT. "WEAK FLUORESCENT SIGNAL COMPARED TO PREVIOUS BATCHES (1 LOG OF DIFFERENCE) (B)(4) UNITS OF SAME LOT". TYPE OF PATIENT IMPACT IF ANY IS UNKNOWN AT THIS TIME. DID THIS RESULT IN ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? YES. IF YES, PLEASE PROCEED TO QUESTION #2. IF NO, NO FURTHER QUESTIONS ARE NECESSARY. WAS AN ERRONEOUS LABORATORY RESULT FROM THE BDB PRODUCT REPORTED TO A CLINICIAN? YES. IF YES, PLEASE PROCEED TO QUESTION #3. IF NO, NO FURTHER QUESTIONS ARE NECESSARY. WAS THERE A CHANGE OR DELAY IN TREATMENT DUE TO THIS ISSUE? DON'T KNOW. IF YES, PLEASE PROCEED TO QUESTION #4. IF NO, PLEASE PROCEED TO QUESTION #5. PLEASE DESCRIBE ANY ADDITIONAL DETAILS. PROCEED TO QUESTION #5. DON'T KNOW. DID THIS ISSUE RESULT IN PHYSICAL DAMAGE/INJURY OR NEGATIVE REPERCUSSIONS FOR THE PATIENT? IF YES, PROCEED TO QUESTION #6. IF NO, NO FURTHER QUESTIONS ARE NECESSARY. DON'T KNOW. PLEASE PROVIDE DETAILS: HOW AND TO WHAT EXTENT? PROCEED TO QUESTION 7. DON'T KNOW. WHAT IS THE CURRENT STATE OF HEALTH? DON'T KNOW.