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 Eye Injury (1845)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

While servicing the cell-dyn sapphire analyzer the tubing popped of and wbc reagent b sprayed into the technician's eyes.Although no eye injury was observed during an exam, the technician was given eye drops (tearprol).

Manufacturer Narrative

The investigation included review of product historical data, product labeling, and review of the incident.Review of product historical data and all customer complaints received for this issue did not identify any adverse trends or abnormal complaint activity.Manufacturing documentation for the analyzer was reviewed and did not identify any issues related to the complaint issue.Review of the incident found the technician was not wearing eye protection.Additionally, it was noted that the field service technician is required to power down/de-pressurize the instrument prior to servicing the reagent panel.Review of labeling sufficiently addresses the issue.The cell-dyn sapphire operator's manual indicates, the user should consider all clinical specimens, reagents, calibrators, and controls that contain human-sourced materials as potentially infectious.Consider all system surfaces or components that have come in contact with human sourced materials as potentially infectious.Additionally, the manual states operators have to make sure they are wearing eye protection and other personal protective clothing.Based on the investigation no product deficiency was identified for the cell-dyn sapphire analyzer.

• 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: 8552434
• MDR Text Key: 143239533
• Report Number: 2919069-2019-00039
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• 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: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WBC REAGENT B; WBC REAGENT B
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR