PHADIA 250
Received Mar 20, 2026 · Event occurred Mar 2, 2026
Report 3004973408-2026-00001 · MDR key 24654292
Device
Generic name
Phadia 250 (phadia Laboratory Instrument)
Manufacturer
Phadia AbModel number
12-3900-01Catalog number
12-3900-01
Lot number
NA
Product problems
- Installation-Related Problem
Patient
NA · Unknown
- Bruise/Contusion
Narrative
Description of Event or Problem
A PHADIA 250 INSTRUMENT WAS SCHEDULED FOR CONNECTION TO A LAS TRACK SYSTEM AT A CUSTOMER SITE IN DENMARK. DURING INSTALLATION, THE INSTRUMENT BECAME UNSTABLE, TIPPED BACKWARD, AND FELL AGAINST THE LAS TRACK POSITIONED BEHIND IT. THE FIELD SERVICE ENGINEER (FSE) WHO WAS TIGHTENING A BRACKET ON THE SIDE OF THE INSTRUMENT WAS STRUCK ON THE WRIST BY THE BRACKET AS THE INSTRUMENT FELL, RESULTING IN A WRIST INJURY.
Additional Manufacturer Narrative
A PHADIA 250 WAS SCHEDULED FOR CONNECTION TO A LAS TRACK SYSTEM. TO INSTALL A PHADIA 250 INSTRUMENT TO THIS TYPE OF LAS (LABORATORY AUTOMATIONS SYSTEM) TRACKS, THE HEIGHT OF THE INSTRUMENT NEEDS TO BE ADJUSTED SINCE IT IS TOO HIGH FOR CONNECTION TO THE TRACK. TO DO THIS, THE EXISTING FEET ON THE INSTRUMENT NEED TO BE REPLACED WITH PARTS FROM PHADIA 250 LAS HARDWARE UPDATE KIT, 12-4907-27. THE PROCEDURE FOR REPLACING THE FEET IS DESCRIBED IN THE ADDENDUM TO PHADIA 250 SERVICE MANUAL, LAS CONNECTION TO LAS. THE PHADIA 250 INSTRUMENT WAS SUPPORTED WITH A LIFT JACK IN ACCORDANCE WITH THE INSTRUCTION, HOWEVER, WHILE THE INSTRUMENT WAS SUPPORTED BY THE LIFT JACK, IT BECAME UNSTABLE, TIPPED OVER BACKWARDS AND FELL AGAINST THE TRACK POSITIONED BEHIND IT. THE FSE WHO WAS TIGHTENING A BRACKET ON THE SIDE OF THE INSTRUMENT WAS STRUCK ON THE WRIST BY THE BRACKET AS THE INSTRUMENT FELL, RESULTING IN A WRIST INJURY. THE FSE RECEIVED MEDICAL EVALUATION, INCLUDING AN X-RAY, WHICH CONFIRMED THAT NO FRACTURE OCCURRED; THE INJURY WAS LIMITED TO SOFT TISSUE STRAIN AND BRUISING. NO SURGICAL INTERVENTION OR HOSPITALIZATION WAS REQUIRED.