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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 Break (1069)
Patient Problem Needle Stick/Puncture (2462)
Event Date 05/06/2014
Event Type  Injury  
Event Description
The abbott field service engineer (fse) punctured his right thumb with a broken glass bubble trap that broke during cleaning on the cell-dyn ruby analyzer.The abbott fse removed his gloves, washed his hands and applied alcohol to the wound.Then, the abbott fse went to the emergency room and received a tetanus vaccine and antiviral treatment of lamivudine, zidovudine and cipla-douvir tablets.Hiv, hepatitis c and hepatitis b testing was performed on the abbott fse with negative results.
 
Manufacturer Narrative
(b)(4).An evaluation is in process.A followup report will be submitted when the evaluation is complete.
 
Manufacturer Narrative
No customer returns were available for evaluation.A product historical data service and parts review did not find any product issues with the likely cause, glass bubble trap.The cell-dyn ruby operator's manual provides adequate information and guidance related to the incident.A review of complaint information shows: - the proper puncture wound treatment or handling was administered to the injured personnel.- preventive medical treatment for blood born communicable diseases was prescribed to the injured personnel.- a definitive medical risk and/or hazard can only be assessed months later when the communicable diseases panel has been re-assessed for the injured personnel.Based on this investigation, it was concluded that there was no product deficiency.
 
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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
Manufacturer (Section G)
ABBOTT DIAGNOSTICS DIVISION
4551 great america parkway
santa clara CA 95054
Manufacturer Contact
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
847937-512
MDR Report Key3836632
MDR Text Key4616545
Report Number2919069-2014-00030
Device Sequence Number1
Product Code GKZ
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K061667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 05/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number08H67-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/03/2014
Initial Date FDA Received05/28/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/26/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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