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

Catalog Number 08H00-01

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/09/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The field service representative (fsr) cut his finger with a cutting tool that slipped while cutting a tubing for replacement on the cell-dyn sapphire.The fsr went to the emergency room where he tested negative for hiv, anti-hcv, anti-hbc, and anti-hbs.The fsr was given antiretrovirus medication to be taken for a month.No patient involved.No specific operator information provided.

Manufacturer Narrative

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.A review labeling included cell-dyn sapphire service and support manual and abbott diagnostic division biosafety requirement procedures.A review of labeling concluded that the issue is sufficiently addressed.A review of the office service and repair kit provides three tools in the kit that can be used to cut the tubing.The picture of the blade provided from field service representative that was used by the field service representative was not specified as part of the tool kit.Use error caused the issue as the field service representative was not following the procedure.No product deficiency 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: 8958767
• MDR Text Key: 156401176
• Report Number: 2919069-2019-00100
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 08H00-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention