MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C8000 SYSTEM; AUTOMATED CHEMISTRY ANALYZER

Catalog Number 01G06-01

Device Problem Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 03/13/2019

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 the laboratory technician was manually washing architect c8000 cuvettes, alkaline wash solution splashed into her eye.She was not wearing personal protective equipment (ppe) at the time of the incident.The technician was examined by a physician and was given medicated eye drops.The technician used the drops for five days and is feeling fine.No additional treatment was required.

Manufacturer Narrative

During the investigation into the customer's issue, it was noted that no other reports of operator injury have been received for the architect system alkaline wash solution, and no trends were identified.Labeling was reviewed and found to be adequate.It was determined that the injury occurred as a result of user error of the operator, as they failed to wear the required personal protective equipment when handling chemical hazards as instructed in the alkaline wash package insert and manufacturing documentation.Based on the investigation, there was no deficiency identified for the architect system alkaline wash solution.

• Brand Name: ARCHITECT C8000 SYSTEM
• Type of Device: AUTOMATED CHEMISTRY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8475727
• MDR Text Key: 140685305
• Report Number: 1628664-2019-00282
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• PMA/PMN Number: K980367
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01G06-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALKALINE WASH SOLUTION; ALKALINE WASH SOLUTION; LIST 09D31-20, LOT 68007UN18; LIST 09D31-20, LOT 68007UN18; ALKALINE WASH SOLUTION; LIST 09D31-20, LOT 68007UN18
• Patient Outcome(s): Required Intervention