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	08/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed wbc results generated on the cell dyn sapphire for 5 patients.The samples were repeated on another analyzer and were correct.The customer stated that there were other cells present in wbc sample (observed after microscopic inspection).The following data was provided: sid (b)(6) bc 0 e9/l, repeated on the same analyzer wbc 2.92 e9/l sid (b)(6) bc 0.005 e9/l, repeated on the same analyzer 5.93 e9/l sid (b)(6) bc 0 e9/l, repeated on the same analyzer 30 e9/l other sample ids with wbc value 0 or nearly 0 (no specific values provided): (b)(6).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.
Additional Manufacturer Narrative
This follow up is being submitted to include the initial coding in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.
Additional Manufacturer Narrative
The field service engineer (fse) visited the site and noticed that peristaltic pump #3 (staging wbc and hgb) was not running intermittently, fse replaced the peristaltic pump #3.Trending review did not identify any trends for the complaint issue.Ticket review did not identify an increase in complaint activity.Labeling was reviewed and found to adequately address the issue under review.Based on all reviewed data, a product deficiency was not identified.Based on all reviewed data, a product deficiency was not 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: 15324447
• Report Number: 2919069-2022-00027
• Device Sequence Number: 17614520
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2022

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: 08/16/2022
• Supplement Date Received by Manufacturer: 09/06/2022; 10/10/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/27/2022; 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2005
• 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