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 Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely depressed hemoglobin (hgb) results between two cell dyn ruby analyzers for 31 patient samples.Impacted results provided were: pt#1 = 6.91 / 8.24g/dl; pt#2 = 7.07 / 8.08; pt#3 = 6.98 / 8.11g/dl.There was no reported impact to patient management.

Manufacturer Narrative

During the site visit by the abbott field service representative the hemoglobin flow cell (hgb flow cell, cdruby, rohs, part number 8921292202) was found leaking and was replaced.This resolved the customer's issue.There were no further issues observed with the hemoglobin and all controls were in range.A review of product historical data for any trends for part number 8921292202 and all customer complaints received for this issue did not identify any trends or additional complaints.A review of the cell dyn ruby, serial number (b)(6) service history revealed no trends or systemic issues.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for either the cell dyn ruby, serial number (b)(6) , or the hgb flow cell, cdruby, rohs, part number 8921292202.

Event Description

The customer reported falsely depressed hemoglobin (hgb) results between two cell dyn ruby analyzers for 3 patient samples.Impacted results provided were: pt#1 = 6.91 / 8.24g/dl; pt#2 = 7.07 / 8.08; pt#3 = 6.98 / 8.11g/dl.There was no reported impact to patient management.

Manufacturer Narrative

Correction to section b.Adverse event or product problem, 5.Describe event - original submission stated 31 patient samples when there were only 3 patient samples.

• 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: 8953822
• MDR Text Key: 184177963
• Report Number: 2919069-2019-00098
• 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,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2019
• 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: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1