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	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased wbc results generated on the cell-dyn sapphire analyzer for multiple patients.The one result example provided were: the one result example provided were: on (b)(6) 2023 sid (b)(6) initial wbc results = 0.048 x 10e3/ul /repeated on 43110az=18.2 10e3/ul /on (b)(6) 2023 repeated on 60088az=16.8 10e3/ul.Neutrophil absolute=0.002 10e3/ul /repeated on 43110az=11.8 10e3/ul/on (b)(6) 2023 repeated on 60088az=473/ 10e3/ul there was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
During the requested site visit, the field service engineer (fse) performed and found an air bubble in the yellowish peristaltic pump tubing (ppt) may have led to the false wbc result.The fse replaced the ppt; however, the ppt had not been changed between the original and repeat runs of sid (b)(6).A review of the product historical data did not find a product issue related to the complaint.Labeling was reviewed and found to be adequate for the complaint issue.Based on the available information no product deficiency of the cell dyn sapphire analyzer, serial number (b)(6), was identified.
Event or Problem Description
The customer observed falsely decreased wbc results generated on the cell-dyn sapphire analyzer for multiple patients.The one result example provided were: the one result example provided were: on (b)(6)2023 sid (b)(6)initial wbc results = 0.048 x 10e3/ul /repeated on 43110az=18.2 10e3/ul /on (b)(6)2023 repeated on 60088az=16.8 10e3/ul neutrophil absolute=0.002 10e3/ul /repeated on 43110az=11.8 10e3/ul / on 26sep2023 repeated on 60088az=473/ 10e3/ul 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17880027
• Report Number: 2919069-2023-00032
• Device Sequence Number: 7666576
• 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): 11/22/2023

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: 09/14/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2020
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown