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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 12/20/2023
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 sprayed clear liquid from ripped peristaltic pump tubing to customer¿s cheek during the troubleshooting for generating flagging on cbc results from cell dyn ruby analyzer.The customer was wearing ppe at the time of incident but did not wear safety glasses at that time.The customer did not seek any medical attention.No further impact to operator.There was no patient involvement.
 
Manufacturer Narrative
A review of all complaints associated and a review of complaint trends for the part numbers was performed.The review did not identify any adverse trends.Additionally, labeling was reviewed and adequately addressed the issue under review.It was determined that the peristaltic pump tubing was damaged (ripped), causing clear liquid to spray from the tubing.Lab personnel wore gloves and coats but did not wear protective eye wear.Based on the information provided, the issue was resolved by service.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the ruby analyzer, serial number (b)(6).
 
Event Description
The customer stated sprayed clear liquid from ripped peristaltic pump tubing to customer¿s cheek during the troubleshooting for generating flagging on cbc results from cell dyn ruby analyzer.The customer was wearing ppe at the time of incident but did not wear safety glasses at that time.The customer did not seek any medical attention.No further impact to operator.There was no patient involvement.
 
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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
nicole jenne
max-planck-ring 2
post market surveillance
wiesbaden N39 E-932
GM   N39 E932
6122582960
MDR Report Key18427163
MDR Text Key331894125
Report Number2919069-2024-00001
Device Sequence Number1
Product Code GKZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K061667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2024
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 Received02/05/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/29/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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