Abbott Cell Dyn 3200 Procedure Manual
ABBOTT DIAGNOSTICS DIVISION/CELLDYN CELL-DYN RUBY ANALYZER AUTOMATED HEMATOLOGY ANALYZER Catalog Number 8H67-01 Device Problem Incorrect or inadequate test results Event Date Event Type Malfunction Manufacturer Narrative Imprecision and calibration on open mode and mode-mode. The customer stated that lab protocol was followed to run spun hematocrit (hct) and verified results before reporting. The customer technical advocate (cta) verified that the hemoglobin reference value and output were within specification and all reagents in use were correct. The cta instructed the customer to clean the optical flow cell and check precision. The precision study yielded results out of specification for mcv, mpv, and platelet. The customer stated they had not cleaned the optical flow cell. The cta requested for the customer to complete cleaning and to rerun the precision.
The cta followed up with the customer who stated that after a recent service visit due to aspiration issues, performing auto cleaning in open mode and then performing mode-mode calibration, qc and patient results recovered well. After checking the qc data, the customer noticed white optical count (woc) and nucleated optical count (noc) being within range with noc trends low at all three levels. The customer cleaned the solenoid valve, dil/sheath filter, sample transfer pipette, and also performed extended auto-clean. The customer agreed to continue monitoring patient results, and agreed that no further assistance was needed at this point as the instrument performance had been verified. No further investigation was needed. The likely cause of the issue was imprecision on multiple parameters and the need for calibration (open mode and mode-mode) to bring recoveries closer to targets.
The cell-dyn ruby system operator's manual, list number 08h56-03, troubleshooting and diagnostics, overview, provides troubleshooting instructions for imprecise or inaccurate data. Calibration procedures, when to calibrate, states that calibration of the cell-dyn ruby may be required when indicated by quality control data. A review of complaints for the period of october 2007 through october 2008, did not indicate any adverse trend for the cell-dyn ruby, list number 08h67-01, related to hemoglobin/hematocrit not matching and having discrepant results. Based on the investigation, no product issue was identified for the cell-dyn ruby, list number 08h67-01, for issues related to hemoglobin/hematocrit not matching and having discrepant results. There was no systemic issue identified for the cell-dyn ruby product line. This is the final report.
Event Description The customer stated hgb/hct values do not match the rule of three and results are imprecise across multiple parameters on the cell-dyn ruby analyzer. A patient sample was tested on both the cell-dyn ruby and cell-dyn 3200 with the following results: cd ruby cd3200rbc 4. 34 m/ulhgb 11.
23 m/ulmcv 93. 4 flhct 38% 29.
2%no impact to patient management was reported. Manufacturer Narrative This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete. Manufacturer Narrative (b)(4). This is an initial report.
Abbott Cell Dyn 3200 Hematology Analyzer
An investigation is in process. A final report will be submitted when the investigation is complete. Date correction from '(b)(6) 2008' to '(b)(6) 2008'.
Brand Name CELL-DYN RUBY ANALYZER Type of Device AUTOMATED HEMATOLOGY ANALYZER Manufacturer (Section D) ABBOTT DIAGNOSTICS DIVISION/CELLDYN 5440 patrick henry dr. Santa clara CA 95054 Manufacturer (Section G) ABBOTT DIAGNOSTICS DIVISION/CELLDYN 5440 patrick henry dr.
Santa clara CA 95054 Manufacturer Contact khaudeja bano 100 abbott park road d09y6, ap6c-2 abbott park, IL MDR Report Key 1222553 Report Number 29-00771 Device Sequence Number 1 Product Code Report Source Manufacturer Source Type Health Professional Reporter Occupation Medical Technologist Type of Report Initial,Followup,Followup Report Date 1 Device Was Involved in the Event 0 PatientS WERE Involved in the Event: Date FDA Received Is This An Adverse Event Report? No Is This A Product Problem Report? Yes Device Operator Health Professional Device Catalogue Number 8H67-01 Was Device Available For Evaluation? Yes Is The Reporter A Health Professional? Yes Date Manufacturer Received Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer Date Device Manufactured Is The Device Single Use? No Is this a Reprocessed and Reused Single-Use Device?
Abbott Cell Dyn 3200
No Type of Device Usage Invalid Data.