BD FACSLYRIC¿

Additional Manufacturer Narrative

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 THE ERROR MESSAGES WERE BYPASSED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST ¿ ERROR MESSAGES 1. IS THIS FACSPRESTO OR FACSCOUNT? IF YES, NO FURTHER QUESTIONS REQUIRED. IF NO, GO TO QUESTION #2. NO. 2. DID THE INSTRUMENT DISPLAY AN ERROR MESSAGE? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED. YES. 3. WHAT ERROR MESSAGE WAS DISPLAYED? (PROVIDE ERROR CODE AND/OR DESCRIPTION) GO TO QUESTION #4. I CAN'T REMEMBER EXACTLY WHAT IT SAYS, BUT IT COMES WHEN PRESSING UPDATE TUBE REFERENCE SETTINGS. I'LL LOOK INTO IT AND SEE IF I CAN'T FIGURE IT OUT. (IT SHOULD BE A KNOWN ISSUE TOO SINCE IT'S A KNOWN BUG FOR 1.6) . 4. DID YOU RUN A DIAGNOSTIC PATIENT ASSAY WITHOUT RESOLVING THE ERROR MESSAGE? IF NO, NO FURTHER QUESTIONS REQUIRED. IF YES, GO TO QUESTION #5 AND THEN GO TO PATIENT SAMPLES CHECKLIST. YES. 5. IF YOU RAN A PATIENT SAMPLE DESPITE THE ERROR MESSAGE STILL BEING PRESENT, WHAT WORKAROUND WAS USED? GO TO PATIENT SAMPLES CHECKLIST. IGNORING THE MESSAGE. JUST PRESS SOMEWHERE ELSE ON THE SOFTWARE AND THE MESSAGE WILL GO TO THE BACKGROUND. IF YOU PRESS ON IT, IT WILL CLOSE THE SOFTWARE, AND USER HAS TO LOG IN AGAIN. THIS WILL HAPPEN REPEATEDLY IF ERROR IS NOT IGNORED AND COSTUMER IS NOT ABLE TO UPDATE TUBE REFERENCE SETTINGS. COSTUMER GETS AN ERROR MESSAGE AFTER 1.6 UPGRADE WHEN THEY PRESS UPDATE TUBE ASSAY. THEY GET IT TWICE A DAY AND IF THEY PRESS ON THE MESSAGE, SUITE CLOSES. SO THE ONLY THING THEY CAN DO IS TO IGNORE IT AND HAVE IT IN THE BACKGROUND.

Additional Manufacturer Narrative

AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. THE CUSTOMER DID NOT BYPASS THE ERROR MESSAGE, IT REMAINED IN THE BACKGROUND. CUSTOMER HAS A WORK AROUND FOR THIS ISSUE, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

Description of Event or Problem

IT WAS REPORTED THAT THE ERROR MESSAGES WERE BYPASSED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST ¿ ERROR MESSAGES 1. IS THIS FACSPRESTO OR FACSCOUNT? IF YES, NO FURTHER QUESTIONS REQUIRED. IF NO, GO TO QUESTION #2. NO 2. DID THE INSTRUMENT DISPLAY AN ERROR MESSAGE? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED. YES 3. WHAT ERROR MESSAGE WAS DISPLAYED? (PROVIDE ERROR CODE AND/OR DESCRIPTION) GO TO QUESTION #4. I CAN'T REMEMBER EXACTLY WHAT IT SAYS, BUT IT COMES WHEN PRESSING UPDATE TUBE REFERENCE SETTINGS. I'LL LOOK INTO IT AND SEE IF I CAN'T FIGURE IT OUT. (IT SHOULD BE A KNOWN ISSUE TOO SINCE IT'S A KNOWN BUG FOR 1.6) 4. DID YOU RUN A DIAGNOSTIC PATIENT ASSAY WITHOUT RESOLVING THE ERROR MESSAGE? IF NO, NO FURTHER QUESTIONS REQUIRED. IF YES, GO TO QUESTION #5 AND THEN GO TO PATIENT SAMPLES CHECKLIST. YES 5. IF YOU RAN A PATIENT SAMPLE DESPITE THE ERROR MESSAGE STILL BEING PRESENT, WHAT WORKAROUND WAS USED? GO TO PATIENT SAMPLES CHECKLIST. IGNORING THE MESSAGE. JUST PRESS SOMEWHERE ELSE ON THE SOFTWARE AND THE MESSAGE WILL GO TO THE BACKGROUND. IF YOU PRESS ON IT, IT WILL CLOSE THE SOFTWARE, AND USER HAS TO LOG IN AGAIN. THIS WILL HAPPEN REPEATEDLY IF ERROR IS NOT IGNORED AND COSTUMER IS NOT ABLE TO UPDATE TUBE REFERENCE SETTINGS. COSTUMER GETS AN ERROR MESSAGE AFTER 1.6 UPGRADE WHEN THEY PRESS UPDATE TUBE ASSAY. THEY GET IT TWICE A DAY AND IF THEY PRESS ON THE MESSAGE, SUITE CLOSES. SO THE ONLY THING THEY CAN DO IS TO IGNORE IT AND HAVE IT IN THE BACKGROUND.