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U.S. Department of Health and Human Services

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

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ABBOTT DIAGNOSTICS DIVISION CELL-DYN RUBY ANALYZER; AUTOMATED HEMATOLOGY ANALYZER Back to Search Results
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.
 
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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 Key8367839
MDR Text Key141115583
Report Number2919069-2019-00008
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00380740017170
UDI-Public00380740017170
Combination Product (y/n)N
PMA/PMN Number
K061667
Number of Events Reported1
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 Number08H67-01
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/30/2019
Initial Date FDA Received02/25/2019
Supplement Dates Manufacturer Received03/28/2019
Supplement Dates FDA Received03/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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