BD FACS¿ LYSE WASH ASSISTANT
Received Feb 1, 2024 · Event occurred Jan 30, 2024
Report 2916837-2024-00012 · MDR key 18624358
Device
Generic name
Station, Pipetting Diluting Clinical Use
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
337146
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D.4. MEDICAL DEVICE EXPIRATION DATE: NA E.1. INITIAL REPORTER ADDRESS 1: (B)(6). 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¿ LYSE WASH ASSISTANT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLE CHECKLIST: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO 3. IF PATIENT SAMPLE WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO ISSUE? NO EMAIL: WE NOTICED TODAY THAT THE SAMPLES THAT RAN LOOKED A LITTLE WEIRD, SO WE RESET THEM AND USED THE OTHER WASHER AND THEY THEN LOOKED NORMAL. BOTH WASHERS GOT PM YESTERDAY AND I THINK SOMETHING HAPPENED DURING THAT. WE DID RUN QC ON IT THIS MORNING AND IT LOOKED OK BUT THE PATIENT SAMPLES LOOKED STRANGE.
Additional Manufacturer Narrative
H.6 INVESTIGATION SUMMARY: BASED ON THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICE ACTIVITY REVIEW, THE COMPLAINT 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 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.
Description of Event or Problem
IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLE CHECKLIST: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO 3. IF PATIENT SAMPLE WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO ISSUE? NO EMAIL: WE NOTICED TODAY THAT THE SAMPLES THAT RAN LOOKED A LITTLE WEIRD, SO WE RESET THEM AND USED THE OTHER WASHER AND THEY THEN LOOKED NORMAL. BOTH WASHERS GOT PM YESTERDAY AND I THINK SOMETHING HAPPENED DURING THAT. WE DID RUN QC ON IT THIS MORNING AND IT LOOKED OK BUT THE PATIENT SAMPLES LOOKED STRANGE.