BD FACS¿ SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WERE PATIENT SAMPLES INVOLVED? YES. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? YES. WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? YES. (B)(6): (B)(6) 2023 07:57:29 (GMT) . ERRONEOUS RESULTS.

Additional Manufacturer Narrative

D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ERRONEOUS RESULTS. WAS IT OBVIOUS THAT THE RESULTS WERE ERRONEOUS/COULD NOT BE TRUSTED? YES, OUR CLIENTS HAD REPEATED THE TESTS AT OTHER LABORATORIES AND THE RESULTS WERE COMPLETELY DIFFERENT FROM OURS IS A CONFIRMATORY TEST ALWAYS PERFORMED? YES, WE DO A RE RUN FOR ALL CD4 ABSOLUTE VALUES OF LESS THAN 150 CELLS/UL WERE PATIENT SAMPLES INVOLVED? YES . WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? YES . WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? YES . IF YES, WAS THERE ANY NEGATIVE IMPACT TO THE PATIENT? YES , PATIENTS WERE ASSUMED TO BE DEFAULTING ON THEIR ARV REGIME, WHICH WAS NOT THE CASE.

Additional Manufacturer Narrative

THE FOLLOWING FIELD WAS UPDATED WITH CORRECTED INFORMATION: H.6. IMDRF ANNEX F CODE: F23. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE ERRONEOUS RESULTS WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: DHR FOR SPA PN647205 AND SN: (B)(6) WAS REVIEWED. THE PRODUCT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. DOM: 11/09/2015. DHR#1532972. FSE CONTACTED CUSTOMER FOR ACCESS TO THE INSTRUMENT FOR FAILURE ANALYSIS. THE CUSTOMER HAS BEEN UNRESPONSIVE AND THEREFORE NO SERVICE VISIT HAS OCCURRED, NOR HAS ANY ADDITIONAL INFORMATION BEEN OBTAINABLE. RECOMMENDATION WAS TO REPLACE THE SPA UNIT AS THEY WERE UNABLE TO FIND FAULT ON THIS SPECIFIC SYSTEM, THE CUSTOMER REFUSED INSTALLATION OF THE NEW SPA DUE TO THE CUSTOMER IS NOT PLANNING ON PURCHASING ANY MORE REAGENTS. POTENTIAL CAUSE: BASED ON THE INVESTIGATION RESULTS, THE POTENTIAL CAUSE WAS NOT DETERMINED. 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 COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

Additional Manufacturer Narrative

B.1- ADVERSE EVENT TYPE: CHANGED FROM- "PRODUCT PROBLEM" TO "REPORTED ISSUE IS BOTH AN ADVERSE EVENT AND PRODUCT PROBLEM". B.3-EVENT ATTRIBUTED TO - CHANGED FROMBLANK TO "OTHER". B.4- OTHER DETAILS - CHANGED FROM BLANK TO "PATIENTS WERE ASSUMED TO BE DEFAULTING ON THEIR ARV REGIME, WHICH WAS NOT THE CASE". B.7 - DESCRIBE EVENT OR PROBLEM- CHANGED FROM: "IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WERE PATIENT SAMPLES INVOLVED? YES. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? YES. WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? YES. (B)(6) : (B)(6) 2023 07:57:29 (GMT) ERRONEOUS RESULTS" TO "IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ERRONEOUS RESULTS WAS IT OBVIOUS THAT THE RESULTS WERE ERRONEOUS/COULD NOT BE TRUSTED? YES, OUR CLIENTS HAD REPEATED THE TESTS AT OTHER LABORATORIES AND THE RESULTS WERE COMPLETELY DIFFERENT FROM OURS IS A CONFIRMATORY TEST ALWAYS PERFORMED? YES, WE DO A RE RUN FOR ALL CD4 ABSOLUTE VALUES OF LESS THAN 150 CELLS/UL WERE PATIENT SAMPLES INVOLVED? YES . WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? YES. WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? YES . IF YES, WAS THERE ANY NEGATIVE IMPACT TO THE PATIENT? YES , PATIENTS WERE ASSUMED TO BE DEFAULTING ON THEIR ARV REGIME, WHICH WAS NOT THE CASE". H.1- "TYPE OF REPORTABLE EVENT" CHANGED FROM "MALFUNCTION" TO "SERIOUS INJURY".

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ERRONEOUS RESULTS WAS IT OBVIOUS THAT THE RESULTS WERE ERRONEOUS/COULD NOT BE TRUSTED? YES, OUR CLIENTS HAD REPEATED THE TESTS AT OTHER LABORATORIES AND THE RESULTS WERE COMPLETELY DIFFERENT FROM OURS IS A CONFIRMATORY TEST ALWAYS PERFORMED? YES, WE DO A RE RUN FOR ALL CD4 ABSOLUTE VALUES OF LESS THAN 150 CELLS/UL WERE PATIENT SAMPLES INVOLVED? YES. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? YES. WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? YES. IF YES, WAS THERE ANY NEGATIVE IMPACT TO THE PATIENT? YES , PATIENTS WERE ASSUMED TO BE DEFAULTING ON THEIR ARV REGIME, WHICH WAS NOT THE CASE.