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

Catalog Number 08H67-01

Device Problems Device Maintenance Issue (1379); Human-Device Interface Problem (2949)

Patient Problems Needle Stick/Puncture (2462); No Patient Involvement (2645)

Event Type  Injury  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation in process.

Event Description

The operator stated the probe was removed from the cell-dyn ruby during troubleshooting.The operator placed the probe in its box for storing when he accidentally hurt himself with the probe.The operator did not receive any disability but was treated with retroviral drugs.

Manufacturer Narrative

The investigation included review of product historical data, product labeling and consultation with medical affairs.Review of product historical data for any trends and all customer complaints received for this issue did not identify any adverse trends or abnormal complaint activity.It is unknown if the operator was wearing personal protective equipment (gloves, safety glasses, and lab coat) because repeated requests for information was unsuccessful.The retroviral treatment is justified, as it has been shown to successfully prevent hiv infection in at-risk subjects.The risk for infection, however, is low, as the probe gets rinsed after every aspiration.The product labeling was reviewed and found to be adequate.The cell-dyn ruby operator's manual provides warning for potential biohazards when handling aspiration probes and vent needles, such as wear lab coats, protective eyewear, gloves and follow biosafety practices.Based on the investigation, the incident was due to a use error for possible failure to follow the warnings in product labeling which could have prevented the incident during handling of the aspiration probe.The cell-dyn ruby analyzer is performing acceptably.

• 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: 6056280
• MDR Text Key: 58354506
• Report Number: 2919069-2016-02247
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2012
• 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
• Patient Outcome(s): Required Intervention