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

Catalog Number	08H00-03
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that a falsely elevated wbc result of 1630/ul was generated in the closed mode on the cell-dyn sapphire analyzer.The patient was known to have aplasia.The sample had followed a very high sample which had generated a result of 258,000/ul.The customer reran the sample in the open mode and a wbc result of 283/ul was generated which was the expected result.There was no report of impact to patient management.
Additional Manufacturer Narrative
It was determined that the cell-dyn sapphire analyzer dilution cup had traces of left over blood in it.In addition, the aspiration needle was bent causing it to rub inside the dilution cup.The issue with the instrument which required troubleshooting, resulted in the discrepant wbc result due to a carryover issue.Cleaning of the wbc dilution well and replacement of the aspiration needle resolved the complaint issue.Customer complaint data was reviewed and no adverse trends or abnormal complaint activity were identified.The cell-dyn sapphire system operation manual was reviewed and was found to adequately address the issue.Based on the available information no product 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: 7011358
• Report Number: 2919069-2017-00155
• Device Sequence Number: 16249056
• Product Code: GKZ
• UDI-Device Identifier: 00380740016623
• UDI-Public: 00380740016623
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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: 10/17/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1