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

Catalog Number 08H67-01

Device Problem Low Test Results (2458)

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

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

All available patient information has been provided.No additional patient information is available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported one patient sample had critically low results for all hematology parameters when processing on the cell-dyn ruby.The patient was sent to the emergency room for a repeat cbc which generated results within normal range.The following data was provided for sid (b)(6): hgb initial and repeat cell-dyn ruby results 6.57 and 6.66 hospital er result 12.9.Ref range 12.0 to 16.0.Hct initial and repeat cell-dyn ruby results 19.7 and 19.8.Hospital er result 37.5.Ref range 37.0 to 47.0.No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, troubleshooting, a review of product historical data and a review of product labeling.Field service identified that the tubing to the vacuum on the mixing tower had popped off its connector and therefore the tubing needed to be reseated.It was determined that the sample error was the result of an improper tubing placement on the instrument.Review of product historical data did not identify any adverse trends or abnormal complaint activity.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• 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: 8786252
• MDR Text Key: 169927435
• Report Number: 2919069-2019-00082
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 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: health professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1