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

Model Number 08H00-01

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: sids = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed discrepancy in the cd4t t cells results generated on the cell-dyn sapphire during a correlation study with the reference lab.The following data was provided (normal range for cd4% is 30 to 61%): correlation performed on (b)(6) 2022.Sid (b)(6).Sapphire cd4% result = 41.9%, labcorp result = 55.2%.Sid (b)(6).Sapphire cd4% result = 22.8%, labcorp result = 30.7%.No impact to patient management was reported.

Manufacturer Narrative

The field service representative (fsr) inspected the instrument, verified 7.0 latex cvs, performed a wbc whole blood verification and adjusted accordingly using calculator.A review of tracking and trending of the product list number and complaint activity did not identify any trends for cell-dyn sapphire instrument with regards to the current issue.The device history records were reviewed, and no non-conformances were identified.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the cell-dyn sapphire for serial number (b)(6) was identified.

• Brand Name: CELL-DYN SAPPHIRE SYSTEM
• Type of Device: 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: 15680121
• MDR Text Key: 306793820
• Report Number: 2919069-2022-00032
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 10/27/2022
• Supplement Dates Manufacturer Received: 12/02/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: C-DYN T-CELL PANL, 07H22-01, (B)(6); C-DYN T-CELL PANL, 07H22-01, (B)(6)