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

Catalog Number 08H00-01

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/14/2019

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.Investigation of the issue included review of the incident, review of product historical data and review of labeling.Review of complaint activity associated with the cell-dyn sapphire analyzer did not identify any other complaints associated with the complaint issue.Review of trending data associated with the cell-dyn sapphire analyzer did not identify any trends.During the review of the incident it was noted that the customer was not wearing any personal protective equipment (ppe) for their face or eyes such as safety glasses, mask or shield.Review of the cell-dyn sapphire operator's manual indicates operators need to wear personal protective equipment when performing service and maintenance or operating the instrument.Based on this investigation, no systemic issue or deficiency of the cell-dyn sapphire analyzer was identified.

Event Description

While troubleshooting the cell-dyn sapphire analyzer the customer was sprayed in the eyes and face with 10% bleach.The customer was not wearing goggles or a mask when the incident occurred.The customer flushed her eyes with the eyewash and no other treatment was necessary.

• Brand Name: CELL-DYN SAPPHIRE 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: 9163850
• MDR Text Key: 184178655
• Report Number: 2919069-2019-00106
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08H00-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2012
• 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