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	06/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 patient identifier : completed sample id's are (b)(6).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 that the cell-dyn sapphire system was generating error code 1061-unexpected tube status at mixhead and further reported falsely low wbc results from samples in the first position on the analyzer rack.The customer reported that repeat testing on the same analyzer was performed and provided the following data: (customer normal range - normal range: 5-10 ^x3 /ul) sample id (b)(6) initial result was 0.331, repeat result was 9.8.Sample id (b)(6) initial result was 0.212, repeat result was 12.1.Sample id (b)(6) initial result was 0.048, repeat result was 15.1.Sample id (b)(6) initial result was 0.239, repeat result was 9.9.There was no reported impact to patient management.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the cell-dyn sapphire s/n: (b)(6) due to generating error code 1061-unexpected tube status at mixhead and falsely decreased wbc results observed by the customer.The fsr inspected the instrument, performed maintenance, including the cleaning of dilution cups, replaced the pinch tubing (tubing, pharmed,.062 inch id x.187 inch od) which was worn out from normal use, and cleaned the pcb assy, irsb (detector), cdsphr because it was dirty.The instrument service history review for the cell-dyn sapphire did not identify any commonalities or concerns.Ticket review did not identify an increase in complaint activity.A review of tracking and trending did not identify any trends related to the tubing, pharmed,.062 inch id x.187 inch od.A review of the manufacturing documentation did not identify any non-conformances or potential non-conformances.A labeling review determined product labeling addresses troubleshooting and resolution of the customer issue.Based on the available information, no systemic issue or deficiency of the cell-dyn sapphire s/n: (b)(6) or the tubing, pharmed,.062 inch id x.187 inch od was identified.
Event or Problem Description
The customer observed that the cell-dyn sapphire system was generating error code 1061-unexpected tube status at mixhead and further reported falsely low wbc results from samples in the first position on the analyzer rack.The customer reported that repeat testing on the same analyzer was performed and provided the following data: (customer normal range - normal range: 5-10 ^x3 /ul).Sample id (b)(6) initial result was 0.331, repeat result was 9.8.Sample id (b)(6) initial result was 0.212, repeat result was 12.1.Sample id (b)(6) initial result was 0.048, repeat result was 15.1.Sample id (b)(6) initial result was 0.239, repeat result was 9.9.There was no reported impact to patient management.

• 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: 17136152
• Report Number: 2919069-2023-00017
• Device Sequence Number: 20276901
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: 06/02/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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