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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN RUBY SYSTEM; COUNTER, DIFFERENTIAL CELL
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ABBOTT LABORATORIES CELL-DYN RUBY SYSTEM; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number 08H67-01
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2020
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 reported a falsely decreased hematocrit (hct) result for a patient while running on the cell-dyn ruby analyzer.The following data was provided: first run on (b)(6) 2020 = hct = 26.1% ; repeat run on (b)(6) 2020 = hct = 41.6% there was no impact to patient management reported.
 
Manufacturer Narrative
The evaluation consisted of review of the complaint issue, the labeling claims, and historical data.The review of the device historical data did not identify any trends or contributing factors related to the issue.Normal complaint activity was identified for the complaint issue.Tracking and trending was reviewed and did not identify any trends for the product related to the complaint.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency for the cell-dyn ruby analyzer was identified.
 
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Brand Name
CELL-DYN RUBY SYSTEM
Type of Device
COUNTER, DIFFERENTIAL CELL
Manufacturer (Section D)
ABBOTT LABORATORIES
4551 great america parkway
santa clara CA 95054
MDR Report Key10987971
MDR Text Key223393496
Report Number2919069-2020-00037
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 foreign,health professional
Type of Report Initial,Followup
Report Date 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number08H67-01
Device Catalogue Number08H67-01
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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