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

Catalog Number 08H67-01

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

There is no further patient information provided due to privacy issues.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer reported the cell dyn ruby rbc results are not matching the alinity hq analyzer.Rbc results are used to calculate the hematocrit (hct), therefore the hct values are elevated on the cd ruby compared to the alinity hq.The customer performs therapeutic phlebotomies on polycythemia vera patients based on the hct and their decision point is >0.45.The patient results provided: on (b)(6) 2019 (b)(6) ruby =0.467 / alinity = 0.416.This patient had an unnecessary therapeutic phlebotomy based on the elevated ruby hct results.

Manufacturer Narrative

A review of product historical data for any trends and all customer complaints received for this issue did not identify any trends or complaints.Return testing was not completed as returns were not available.The red blood cells (rbc) measured significantly higher on the ruby than the alinity, the platelets (plt) measured significantly lower on the ruby than the alinity, and the hemoglobin and the mcv showed good agreement between the analyzers.The difference in the rbc measurement is the contributing factor for the higher hct results reported from the ruby.On 19sep2019, the ruby serial number (sn) (b)(4) analyzer was calibrated to ruby sn (b)(4) to correct rbc, plt and hct bias between this analyzer and all other fbc analyzers in the hospital.On 11oct2019, comparison studies between all hematology analyzers in the hospital found the hct, rbc and plt results to be acceptable.The most likely explanation for the incident is that even though both instruments are calibrated with their own calibrators properly, to compare results, the two instruments need to be cross calibrated according to the method described in clsi h26-a2, the alinity hq operations manual, and the cell-dyn ruby operator's manual.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the cell-dyn ruby, sn (b)(4).

• 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: 8953789
• MDR Text Key: 184177640
• Report Number: 2919069-2019-00095
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other