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

Catalog Number 08H00-01

Device Problem High Test Results (2457)

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

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a falsely elevated hemoglobin result on the cell-dyn sapphire analyzer.The customer indicated a patient sample was tested on three different analyzers.Two analyzers generated critical results of 55 and 56 g/l and the sapphire generated a result of 92 g/l.No specific patient information was provided and no adverse impact to patient management was reported.

Manufacturer Narrative

The investigation included review of submitted data, product historical data, product labeling, as well as consultation with medical affairs and on-market engineer.Review of product historical data for any trends and all customer complaints received for this issue did not identify any adverse trends or abnormal complaint activity.The customer's instrument logs for two of the three analyzers (including (b)(4)) were reviewed and found the sample was run in open mode on the cell-dyn sapphire analyzers.Background counts and quality control recovered within specification and within the published assay range before the sample in question was run.Review of the provided data found multiple results obtained from the two comparison instruments (b)(4) were different from (b)(4) including: hgb, wbc, rbc, rbco, plt, plti and pic/poc delta message.Given the fact that the sample run on serial number (b)(4) with the higher hgb had lower wbc and plt results, aspiration error was excluded as a possible cause.However, a sample error caused by user error may have contributed to the issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information, 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: 7228622
• MDR Text Key: 98846552
• Report Number: 2919069-2018-00011
• 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: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08H00-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1