MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) ARCHITECT C8000 SYSTEM; AUTOMATED CHEMISTRY ANALYZER

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem Injury (2348)

Event Date 06/07/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported during troubleshooting of the architect c8000 analyzer, the user was splashed on her face.The user to follow their lab protocol for splashes.The user was not using any personal protective equipment at the time of the incident.The user sought treatment which included preventative viral medication (user is unknown of the name of medication).The user is doing ok and no resulting harm was reported.

Manufacturer Narrative

User error may have contributed to the complaint issue regarding the use of personal protective equipment (ppe) and properly removing the ict module from the analyzer.No protective eyewear as per product labeling was in use at the time of the incident.The customer indicated that she had reviewed the ict module removal procedure and was determined after subsequent follow up that significant steps were skipped or not performed correctly.A review of the analyzer's service history identified no contributing factors regarding ict module removal injuries since the current incident.A review of tracking and trending data determined no trends for the ict module and analyzer associated with the complaint issue.The search for similar complaints identified no additional complaints of ict module related injuries.A device history review did not identify any issues related to the complaint issue.Labeling was reviewed and adequately addresses the biological and chemical safety hazards that may exist.Also, the labeling was reviewed and adequately addresses the proper removal and replacement of the ict module.Based on the information, the device performed as intended and no systemic issue or deficiency was identified.

• Brand Name: ARCHITECT C8000 SYSTEM
• Type of Device: AUTOMATED CHEMISTRY ANALYZER
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 10195089
• MDR Text Key: 196429353
• Report Number: 3016438761-2020-00102
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: 00380740000509
• Combination Product (y/n): N
• PMA/PMN Number: K980367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01G06-11
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/07/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 08/09/2020
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention