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 Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient information: no specific information was provided.

Event Description

While troubleshooting an issue with the cell-dyn sapphire analyzer the customer was splashed on the chin and forehead.The issue occurred while the customer was performing a flush with distilled water.The customer indicated there was no exposure to membranes, eyes, mouth or nasal passages.The customer washed their face with soap and alcohol wipes, and followed the lab protocol for exposures.No treatment was necessary.

Manufacturer Narrative

Investigation of the customer's issue included a review of the complaint text, review of the product historical data and labeling.Review of manufacturing documentation and trending data associated with the analyzer did not identify any issues or trends.Review of the incident found the user was not wearing protective eye wear and did not follow the appropriate procedure to place the instrument in a safe servicing state.Labeling was reviewed and sufficiently addresses the issue.The cell-dyn sapphire operator's manual instructs the servicing personel to "put the instrument in a safe servicing state by selecting, disable for service, in the special protocols window instead of clean loader components.Disabling the instrument for service depressurizes all of the fluidics and pneumatic lines to prevent splashes or spills of liquids." based on this investigation no systemic issue or deficiency of the cell-dyn sapphire analyzer was identified.

• 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
• MDR Report Key: 9351192
• MDR Text Key: 184179112
• Report Number: 2919069-2019-00110
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (y/n): N
• PMA/PMN Number: K051215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• 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?: Yes
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1