inforMED
InjuryJQP

C8100V2 BETA(IPB,DSP,BCL,AQM,OBS,CRW,CU)

Received Jul 6, 2026 · Event occurred Mar 11, 2026

Report 1823260-2026-02687 · MDR key 25716398

Device

Generic name

Automated Preanalytical System

Manufacturer

Roche Diagnostics

Catalog number

07439920001

Product problems

  • Use of Device Problem

Patient

NA · Male

  • Laceration(s)
  • Unspecified Tissue Injury

Narrative

Description of Event or Problem

WE RECEIVED AN ALLEGATION THAT A PANEL ON A COBAS 8100 INSTRUMENT WAS NOT SEATED PROPERLY AND FELL ONTO A STAFF MEMBER¿S FOOT, RESULTING IN AN INJURY. THE STAFF MEMBER WAS TAKEN TO THE HOSPITAL AND REPORTEDLY RECEIVED STITCHES ON HIS FOOT. THE STAFF MEMBER WAS REPORTEDLY WEARING APPROPRIATE FOOTWEAR. ALLEGEDLY, THE STAFF MEMBERS' DUTIES WERE INITIALLY ADJUSTED TO ENSURE THAT THEY DID NOT NEED TO STAND TO AVOID PLACING WEIGHT ON THE LEFT FOOT. THE STAFF MEMBER HAS REPORTEDLY FULLY RECOVERED AND HAS RETURNED TO WORK. THE STAFF MEMBER HAD NO PERMANENT HARM OR INJURY.

Additional Manufacturer Narrative

THE CUSTOMER ALLEGEDLY REMOVES PANELS TO INVESTIGATE ISSUES BEFORE REQUESTING SERVICE. DURING TROUBLESHOOTING FOR THIS EVENT, IT WAS FOUND THAT 50 FIXING SCREWS WERE MISSING. IT COULD NOT BE DETERMINED WHY THE PANEL WAS NOT SEATED APPROPRIATELY OR WHO REMOVED THE SCREWS. THE SCREWS HAVE SINCE BEEN REPLACED. BASED ON THE INFORMATION PROVIDED, THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.