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

Catalog Number 08H67-01

Device Problem High Readings (2459)

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

Event Type  malfunction  

Manufacturer Narrative

All available patient information has been included.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 discrepant hemoglobin results for a male patient when processing on the cell-dyn ruby.The customer reported the patient has a known history of low hemoglobin and platelet results.The initial hemoglobin result was 4.79 and retest using the same analyzer was 9.41.The customer repeated the sample on a different ruby analyzer and the hemoglobin result was 4.29.The customer uses a normal range of 14.0-18.0 for hemoglobin.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, review of product historical data, troubleshooting, and review of product labeling.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.Based on complaint information, the field service engineer replaced the following parts: a.8921204903, shear valve assembly b.8921016301, hgb lyse - v28 nc valve c.9130543, hgb pathway tubing after the troubleshooting, the instrument passed precision test and control were within range.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: 8679104
• MDR Text Key: 169927310
• Report Number: 2919069-2019-00066
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• 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: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1