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

Catalog 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	09/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6) and (b)(6) (2 different samples for the same patient).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section g1 contact information was updated to reflect the current contact (b)(6) deu.
Event or Problem Description
The customer observed falsely decreased wbc results for multiple patient samples when running on the cell dyn sapphire.The customer provided data for one patient: on (b)(6) 2023: sid (b)(6) was a first draw that generated wbc result of 0.142 x 10e3/ul which was reported to the medical provider.Sid (b)(6) was a redraw from same patient that generated normal wbc result of 11.1 x 10e3/ul.Customer reran the first sample sid (b)(6) which generated a normal wbc result of 10.6 x10e3/ul there was no impact to patient management reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument and an air bubble in the yellowish peristaltic pump tubing (ppt) was found.The fsr replaced the ppt, piston pump, and wbc mixing pot which resolved the issue.Return testing was not completed as returns were not available.A review of tracking and trending for the cell-dyn sapphire did not identify any trends.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the cell-dyn sapphire analyzer for serial (b)(6) was identified.Correction: upon review, found incorrect response to section d8 - was device serviced by third party - initial answer: ni was inadvertently sent in previous submission.The response will be corrected and sent in this submission.
Event or Problem Description
The customer observed falsely decreased wbc results for multiple patient samples when running on the cell dyn sapphire.The customer provided data for one patient: on (b)(6) 2023: sid (b)(6) was a first draw that generated wbc result of 0.142 x 10e3/ul which was reported to the medical provider.Sid (b)(6) was a redraw from same patient that generated normal wbc result of 11.1 x 10e3/ul customer reran the first sample sid (b)(6) which generated a normal wbc result of 10.6 x10e3/ul 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17882891
• Report Number: 2919069-2023-00033
• Device Sequence Number: 6976597
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 12/01/2023

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 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: Not provided
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2011
• 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