BD FACS¿ LYSE WASH ASSISTANT

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBTAINED ON PATIENT SAMPLES DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PREPARER DOES NOT LYSE THE SAMPLES CORRECTLY AND THE VOLUME IS NOT CORRECT. MDR SAFETY CHECKLIST -- PATIENT SAMPLES (CASE): 1.ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST?(IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED): YES. 2.WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? UNKNOWN. 3.IF THE PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. 4.WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE?NO. 5.PROVIDE DETAILS ¿ HOW AND TO WHAT EXTENT? IT WAS NOT NEEDED TO REDRAW THE PATIENTS BECAUSE THERE WAS ENOUGH SAMPLE TO REPEAT MANUALLY THE PREPARATION. THERE WAS A DELAY IN THE DIAGNOSIS BUT AT THE MOMENT SHE DOESN¿T KNOW IF THERE WILL BE A DELAY IN THE TREATMENT.

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.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE - BECTON DICKINSON AND COMPANY BD BIOSCIENCES SAN JOSE CA, 95131 G.1 - REPORTING OFFICE CONTACT - (B)(6). G.1 - MANUFACTURING SITE CONTACT - (B)(6). H.6 - IMDRF ANNEX F: F26. INVESTIGATION SUMMARY: BASED ON THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICE ACTIVITY REVIEW, THE ISSUE 'DOES NOT LYSE THE SAMPLES CORRECTLY' WAS CONFIRMED, AND THE POTENTIAL CAUSE OF THE UNEXPECTED RESULTS WAS DETERMINED TO BE OBSTRUCTIONS IN THE WASH ARM. THE FSE DISASSEMBLED THE ARM, CLEANED, AND LUBRICATED IT AND SUBSEQUENT TESTING SHOWED THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO PATIENTS WERE DIAGNOSED OR TREATED BASED ON ANY ERRONEOUS RESULTS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. COMPLAINTS RECEIVED FOR THIS DEVICE 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.

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBTAINED ON PATIENT SAMPLES DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PREPARER DOES NOT LYSE THE SAMPLES CORRECTLY AND THE VOLUME IS NOT CORRECT MDR SAFETY CHECKLIST -- PATIENT SAMPLES (CASE): 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED): YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? UNKNOWN. 3. IF THE PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. 5. PROVIDE DETAILS ¿ HOW AND TO WHAT EXTENT? IT WAS NOT NEEDED TO REDRAW THE PATIENTS BECAUSE THERE WAS ENOUGH SAMPLE TO REPEAT MANUALLY THE PREPARATION. THERE WAS A DELAY IN THE DIAGNOSIS BUT AT THE MOMENT SHE DOESN¿T KNOW IF THERE WILL BE A DELAY IN THE TREATMENT.