GLP Input/Output Module
Received Jun 30, 2026 · Event occurred Jun 17, 2026
Report 3023268435-2026-00008 · MDR key 25664059
Device
Generic name
Calculator/data Processing Module, For Clinical Use
Manufacturer
Abbott Automation Solutions GmbhCatalog number
04Z96-01
Product problems
- Thermal Decomposition of Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Description of Event or Problem
THE CUSTOMER REPORTED THAT A SAMPLE TUBE BECAME DETACHED FROM THE GRIPPER, RESULTING IN A LIQUID SPILL THAT CONTACTED AND WETTED THE CIRCUIT BOARD AND BOARD BECAME DEFECTIVE INSIDE THE GLP INPUT/OUTPUT MODULE (IOM). DURING SITE VISIT, THE FIELD SERVICE REPRESENTATIVE (FSR) OBSERVED THAT DRAWER FOR ATR CONTROLLER #2 WAS NO LONGER ABLE TO BE OPENED. UPON FURTHER INSPECTION, THE FSR IDENTIFIED BURN MARKS ON THE CIRCUIT BOARDS OF ATR CONTROLLER #2 AND ATR CONTROLLER #3. BOTH ATR CONTROLLER ASSEMBLIES WERE REPLACED, AND THE REPLACEMENT RESOLVED THE ISSUE, AND THE DRAWERS WERE SUCCESSFULLY INITIALIZED AND RETURNED TO NORMAL OPERATION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.