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

Model Number 08H67-01

Device Problem Leak/Splash (1354)

Patient Problem Injury (2348)

Event Date 04/23/2020

Event Type  Injury  

Manufacturer Narrative

Use error may have contributed to the customer's issue regarding the use of personal protective equipment (ppe) while using the product.No trends or similar issues for splashing/exposure as described in this ticket were identified.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Labeling was reviewed and found to adequately address the biological and chemical safety hazards that may exist.Based on the investigation no product deficiency was identified.

Event Description

The customer reported a diluent/sheath splash occurred to the operator's eye on (b)(6) 2020.This was caused by a tubing to the diluent syringe that was disconnected during troubleshooting by the operator and inadvertently not reconnected upon processing of the cell-dyn ruby analyzer.The operator was using ppe including an apron, gloves, mask and eyeglasses, but removed the protection to verify if the tubing was damaged.This is when the diluent splashed into the right eye of the operator.The operator flushed the eye and sought treatment which included preventative administration of tenofovir, lamivudine and dolutegravir.The operator is doing ok now and no resulting harm was reported.

• 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: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 10057152
• MDR Text Key: 191435296
• Report Number: 2919069-2020-00015
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 08H67-01
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention