MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT PLUS C4000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number 2P24-40

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2019

Event Type  malfunction  

Event Description

During routine cleaning of the c4000 chemistry analyzer the instrument mechanics began behaving sporadically and uncharacteristically from its normal function.Motor movement, temperature and alternating current / direct current (ac/dc) controller errors appeared on the console screen.The cover showed minor amount of fluid, a little more than a few drops.The cover was removed to find a small amount of fluid directly beneath the covers.The fluid had dripped down into the card cage from the air vents atop the cage, beneath the liquid level sense (lls) board housing.The fluid dripped down from the vent, ran down several of the boards (ac/dc controller, ac/dc service module (sm), central processing unit (cpu)) into the cooling fans below the cards, that then sprayed fluid upward and around the insides of the card cage.Discovery is that the c4000 chemistry analyzer is easily subject to fluid intrusion by operators and/or trained service engineers.All the fluids are located directly above the electronics cage where all the printed circuit board assemblies (pcba's) are located.This fluid should be diverted from the cage and the fans.This design caused serious failures and delays to patient diagnosis for the laboratory.Manufacturer response for c4000 chemistry analyzer, architect plus c4000 (per site reporter).Manufacturer made aware.Continued discussion with manufacturer and (b)(4) and our biomed team.

• Brand Name: ARCHITECT PLUS C4000
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• MDR Report Key: 9375554
• MDR Text Key: 168003920
• Report Number: 9375554
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2P24-40
• Device Catalogue Number: 2P2440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2019
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1