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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
Catalog Number 08H67-01
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2023
Event Type  malfunction  
Manufacturer Narrative
This product is marketed internationally to multiple countries.Additional shipping history on lot/list basis is available upon request.Verify your country registration status prior to vigilance reporting to ensure proper legal manufacturer and product classification is utilized in your reports.
 
Event Description
A clogged waste line from a cell-dyn ruby analyzer sprayed once removed causing exposure to the eye of an abbott fse.The individual ran to the eye wash station and cleaned the exposed eye for approximately 5 minutes.After this, the individual went to the er, where a general practitioner irrigated the eye and recommended to take a hepatitis b virus immunoglobulin, however it was not administered.Aside from the eye wash/irrigation, it was confirmed that there has been no other treatment provided or administered as a result of the exposure event.
 
Manufacturer Narrative
Section b5 has been updated with additional information received.
 
Event Description
A clogged waste line from a cell-dyn ruby analyzer sprayed once removed causing exposure to the eye of an abbott fse.The individual ran to the eye wash station and cleaned the exposed eye for approximately 5 minutes.After this, the individual went to the er, where a general practitioner irrigated the eye and recommended to take a hepatitis b virus immunoglobulin, however it was not administered.Aside from the eye wash/irrigation, it was confirmed that there has been no other treatment provided or administered as a result of the exposure event.Update: additional information received on 5 aug 2023: no eye protection was being worn at the time of the event.The recommendations of the medical provider were further clarified, which included laboratory work hepatitis b vaccine and immunoglobulin.
 
Event Description
A clogged waste line from a cell-dyn ruby analyzer sprayed once removed causing exposure to the eye of an abbott fse.The individual ran to the eye wash station and cleaned the exposed eye for approximately 5 minutes.After this, the individual went to the er, where a general practitioner irrigated the eye and recommended to take a hepatitis b virus immunoglobulin, however it was not administered.Aside from the eye wash/irrigation, it was confirmed that there has been no other treatment provided or administered as a result of the exposure event.Update: additional information received on (b)(6) 2023: no eye protection was being worn at the time of the event.The recommendations of the medical provider were further clarified, which included laboratory work hepatitis b vaccine and immunoglobulin.
 
Manufacturer Narrative
Cell-dyn ruby, serial number serial number:(b)(6) was inspected and determined that there was an issue with the vacuum accumulator.A waste line was clogged, and it was removed.Return testing was not completed as returns were not available.A review of tracking and trending did not identify a trend or an increase in complaint activity with regards to the customer issue.A review of the manufacturing documentation determined there were no non-conformances or potential non-conformances for the vacuum accumulator.A labeling review determined product labeling addresses troubleshooting and resolution of the customer issue.Based on the available information, no systemic issue or deficiency of the cell-dyn ruby, serial number serial number: (b)(6) or vacuum accumulator 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
Manufacturer (Section G)
ABBOTT LABORATORIES
4551 great america parkway
santa clara CA 95054
Manufacturer Contact
siobhan wright
lisnamuck
post market surveillance
longford N39 E-932
EI   N39 E932
433331157
MDR Report Key17454110
MDR Text Key320391195
Report Number2919069-2023-00021
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00380740017170
UDI-Public00380740017170
Combination Product (y/n)N
Reporter Country CodeSA
PMA/PMN Number
K061667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2023
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/06/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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