MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN SAPPHIRE ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Model Number 08H00-01

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported that the results on the lis did not match those on the cell dyn sapphire screen.No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of complaint text, a review of trending data and a review of product labeling.A review was performed for any trends and all customer complaints received for this issue.The review of this data did not identify any trends.Return sample analysis is not applicable because returns are not available.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• Brand Name: CELL-DYN SAPPHIRE ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 9432913
• MDR Text Key: 190383887
• Report Number: 2919069-2019-00116
• 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: 03/25/2020

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
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1