MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN SAPPHIRE SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	08H00-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely decreased white blood cell (wbc) and neutrophil counts for one patient on a cell-dyn sapphire analyzer.The following data was provided: sample id (b)(6) initial wbc result was 0.568, repeats were 7.912 and 7.428 10e9/l; initial neutrophil result was 0.068, repeats were 5.609 and 5.209 10e9/l there was no impact to patient management reported.
Additional Manufacturer Narrative
An abbott field service representative (fsr) was dispatched due to the customer reporting a falsely decreased white blood cell and absolute neutrophil counts on the cell-dyn sapphire analyzer, serial number (b)(6).Through an extensive investigation, the fsr found the pump assy, perist, cdsphr, part number 8921276501, perist pmp tbg-md, list number 91485-01, cdsphr rgt srng x, list number 08h45-01, cdsphr retic srng, list number 08h48-01, needed to be replaced.The fsr also replaced the ftg barb rdcr.093 x.062 kyna rohs, part number 8310820202, located at the optical rbc/plt transfer pump, as it was found to be slightly bent.The fsr also flushed/cleaned the hemoglobin fluidics pathway.All of which resolved the issue.No subsequent issues have been reported.A review of the instrument history revealed no contributing factors described in this complaint.A review of labeling and historical data was done, and both were adequate, with no trends found.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency was identified.
Event or Problem Description
The customer observed falsely decreased white blood cell (wbc) and neutrophil counts for one patient on a cell-dyn sapphire analyzer.The following data was provided: sample id (b)(6) initial wbc result was 0.568, repeats were 7.912 and 7.428 10e9/l; initial neutrophil result was 0.068, repeats were 5.609 and 5.209 10e9/l there was no impact to patient management reported.

• Brand Name: CELL-DYN SAPPHIRE SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16997907
• Report Number: 2919069-2023-00015
• Device Sequence Number: 7039972
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 08H00-01
• Device Catalogue Number: 08H00-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/30/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown