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 Consequences Or Impact To Patient (2199)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer stated that discrepant results were generated for multiple parameters for a patient sample (id (b)(6)) tested on the cell-dyn ruby analyzer.The same sample was tested four times.Wbc 9.74, 3.16, 10.0 and 9.58 k/ul, hemoglobin 7.63, 20.7, 7.17 and 7.07 g/dl, platelets 85.7, 32.6, 89.3 and 80.8 k/ul.The customer stated the sample was mixed properly with no clots and that there was no sample mixup between repeats because the sample was barcoded.No adverse impact to patient management was reported.

Manufacturer Narrative

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.Review of the submitted numerical data, histograms and scatterplots showed that the first run of both specimens was in sample loader, and the following runs of both specimens were in open tube mode.The results were repeatable except for the two samples that were run 30 mins and 1hour 20 mins after the first sample (auto loader).The results suggest that the samples might have not been (properly) mixed before aspiration in open tube mode.When a sample is not mixed, sedimentation of rbc occurs within minutes, making the sample inhomogeneous: more rbc at the bottom, and more plt are on top.The results of the second runs for both samples are consistent with sedimentation, as both rbc and hgb are elevated compared to the first result (in auto loader).It appears that the samples were mixed before the third and fourth runs, therefore the obtained results were close to the original results from the first run.Labeling was reviewed regarding specimen mixing instructions and was found to be adequate.Based on the available information, no product deficiency was 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: 8367839
• MDR Text Key: 141115583
• Report Number: 2919069-2019-00008
• 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: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/25/2019
• Supplement Dates Manufacturer Received: 03/28/2019
• Supplement Dates FDA Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1