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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 High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2023
Event Type  malfunction  
Event Description
The customer observed falsely elevated white blood cell (wbc) results generated from cell dyn ruby analyzer for several patients.The one result example provided which does not match with patient clinical picture.The results were: initial=93 10e3/ul /repeated=90 and 85 10e3/ul.The customer expected to be normal wbc result within normal laboratory reference range for this patient.Laboratory reference range for wbc=5 to 10 10e3/ul there was no reported impact to patient management.
 
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Manufacturer Narrative
During the requested site visit, the field service engineer (fse) performed troubleshooting procedures and found that accumulated dirt was found in the tubing connected to the flow cell.A review of the tracking and trending report determined that there are no trends for the product for the complaint issue.A review of all complaints associated and a review of complaint trends for the list number was performed.The review did not identify any adverse trends.Additionally, labeling was reviewed and adequately addressed the issue under review.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 observed falsely elevated white blood cell (wbc) results generated from cell dyn ruby analyzer for several patients.The one result example provided which does not match with patient clinical picture.The results were: initial=93 10e3/ul /repeated=90 and 85 10e3/ul the customer expected to be normal wbc result within normal laboratory reference range for this patient.Laboratory reference range for wbc=5 to 10 10e3/ul there was no reported impact to patient management.
 
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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 Key18093776
MDR Text Key327652234
Report Number2919069-2023-00046
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00380740017170
UDI-Public00380740017170
Combination Product (y/n)N
Reporter Country CodeMX
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
Report Date 01/23/2024
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/20/2023
Initial Date FDA Received11/08/2023
Supplement Dates Manufacturer Received01/23/2024
Supplement Dates FDA Received01/23/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2020
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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