MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN RUBY ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

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.

• 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 Key: 3836632
• MDR Text Key: 4616545
• Report Number: 2919069-2014-00030
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• 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 Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2014
• Initial Date FDA Received: 05/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention