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

Catalog Number 08H00-03

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.Section a.Patient information: no specific patient information was provided.

Event Description

The cell-dyn sapphire analyzer generated a falsely elevated platelet results and low %neutrophil results.Sample id (b)(6) generated platelet results of 21.8, 16.5, 14.9 and 16.62.Additionally, multiple samples generated %neutrophil results less than 2.5%.No impact to patient management was reported.

Manufacturer Narrative

Further evaluation of the customer issue included a review of the complaint data, a search for similar complaints, and a review of labeling.Review of the cell-dyn sapphire tracking and trending data did not identify any adverse trends or abnormal complaint activity.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information and this investigation, no systemic issue or deficiency of the cell-dyn sapphire analyzer was 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: 8384856
• MDR Text Key: 137704548
• Report Number: 2919069-2019-00010
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740016623
• UDI-Public: 00380740016623
• 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: 04/02/2019

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 Catalogue Number: 08H00-03
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/03/2019
• Supplement Dates Manufacturer Received: 03/20/2019
• Supplement Dates FDA Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1