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

Model Number 08H67-01

Device Problem Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation is in process.

Event Description

The account questioned if the cell-dyn ruby generated mismatched results for 3 patient sample ids.The account processed 3 samples in closed mode on the cell-dyn ruby but when the sample was validated in the lis system it appeared the samples were not processed.The samples were then processed by open mode but when the sample label was read the previously processed cbc result by closed mode including rack and tube position showed on the screen.The operator tried to clear the data by turning off the power to the cell-dyn ruby, but when powered on, the data record showed cbc results with "no id" instead of the sample id.The operator does not remember if any incorrect id was associated with incorrect results.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

A review of historical data did not identify any adverse trends during a 12 month search period.A review of the product labeling concluded that the issue is sufficiently addressed.The investigation determined possible causes for the issue.One, a mistake in lis setup can cause closed mode tests to drop.Two, a delay in lis communication can cause the closed mode test results to show up late.Especially if serial (b)(4) communication link is being used.Three, if the system detected some issue of the entered id, it might show it as no id.Four, in open mode, power off the system during test process can cause the no id to show up if the system did not have enough time to update the database to store the test result.Based on the investigation no product deficiency found for cell-dyn sapphire and barcode reader, scanner for the complaint issue.

• Brand Name: CELL-DYN RUBY ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 7392963
• MDR Text Key: 104591450
• Report Number: 2919069-2018-00023
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)00380740017170
• Combination Product (y/n): N
• PMA/PMN Number: K061667
• 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: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08H67-01
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1