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	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased wbc and neutrophil results generated on the cell-dyn sapphire analyzer for 2 samples that were not reported out.The samples were repeated with lower results.The following data was provided: both samples processed on (b)(6) 2023.Sid (b)(6) initial wbc result = 0.436 10e3/ul repeat wbc = 11.7 10e3/ul initial neutrophil result = 0.024 10e3/ul repeat result = 7.86 10e3/ul.Sid (b)(6) initial wbc result = 0.365 10e3/ul repeat wbc = 7.77 10e3/ul initial neutrophil result = 0.049 10e3/ul repeat result = 5.64 10e3/ul no impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for section a1 patient identifier: sid (b)(6).
Additional Manufacturer Narrative
The customer reported falsely decreased wbc and neutrophil results for two patients on the cell-dyn sapphire, serial number (s/n) (b)(6).The issue was resolved after field service reseated tubing (part number 9130687) and flushed the affected (wbc) pathways.A review of all complaints associated and a review of complaint trends for the list number was performed.The review did not identify any adverse trends.Additionally, labeling was reviewed and adequately addressed the issue under review.Based on the investigation, no systemic issue or deficiency of the cell-dyn sapphire, serial number (s/n) (b)(6) was identified.

• 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: 16931318
• Report Number: 2919069-2023-00014
• Device Sequence Number: 12496356
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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): Initial
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2014
• 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