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

Model Number 08H00-01

Device Problem Low Readings (2460)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier is sid (b)(6).No additional patient information available.

Event Description

The customer questioned results generated with the cell-dyn sapphire.The customer provided the following data: sid (b)(6), run date (b)(6) 2020, cd4t initial 0.332, repeat 0.489 no impact to patient management was reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, review of product historical data, and a review of labeling.This review did not find a product issue related to the complaint incident and no trends were identified.Return testing was not completed as returns were not available.Review of data found that some of the cell populations appear to be dual populations on the cd3/4 fl1/fl2 and cd3/8 fl1/fl2 scatterplots, containing cells with different staining intensities.Labeling was reviewed and found to be adequate.Based on the investigation no systemic issue or deficiency of the no product deficiency was identified for the cell-dyn t-cell panel, list number: (b)(4) was identified.

Event Description

The customer questioned results generated with the cell-dyn sapphire.The customer provided the following data: sid (b)(6), run date (b)(6) 2020.Cd4t initial 0.332, repeat 0.489 no impact to patient management was reported.

• 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
• MDR Report Key: 11007837
• MDR Text Key: 223392930
• Report Number: 2919069-2020-00039
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (y/n): N
• PMA/PMN Number: K051215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• 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
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: C-DYN T-CELL PANL, (B)(4), UNKNOWN.