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

Catalog Number 08H67-01

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided.

Event Description

During removal of tubing from the cell-dyn ruby analyzer for cleaning, the customer was sprayed in the face and mouth with a mixture of system waste, diluent, and blood.The customer was wearing safety glasses at the time of the incident.The customer did not receive any treatment after the incident.A blood sample was taken for hiv and hepatitis testing, however the results of the tests were not provided.

Manufacturer Narrative

The customer reported that they are doing fine after the incident and no treatment was received as a result of the spray incident.Evaluation of the customer issue included a review of the complaint text, a review of labeling, a review of instrument service, and a search for similar complaints.No returns were made available from the customer site for this evaluation.Product labeling was reviewed and found to be adequate.Cell-dyn ruby operators manual, section 8, hazards, provides several warnings and information related to biological hazards during analyzer use, maintenance and troubleshooting.The manual states to disable the instrument to prevent the analyzer from cycling during maintenance and troubleshooting.The operator did not put the cell-dyn ruby in disable mode which could have prevented the spray incident.In this case, the analyzer was in ready mode when the incident occurred, and pressure in the tubing when it was removed from the analyzer caused the spray incident.This indicates the issue was due to user error.Cell-dyn ruby analyzer serial number (b)(4) service history was reviewed and no contributing factors were found no other incident related to splash, spill, or spray was identified.Historical complaint data was reviewed and no adverse trend was identified.Based on all available information and abbott diagnostics complaint investigation for the cell-dyn ruby analyzer, no product deficiency and no malfunction was identified.

• 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 ; 224667-512
• MDR Report Key: 6038616
• MDR Text Key: 57800634
• Report Number: 2919069-2016-02191
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1