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

Catalog Number	08H00-03
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 8384856
• Report Number: 2919069-2019-00010
• Device Sequence Number: 16609048
• Product Code: GKZ
• UDI-Device Identifier: 00380740016623
• UDI-Public: 00380740016623
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K051215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 08H00-03
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 03/03/2019
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1