LIGHTCYCLER 480 (384 WELL)
Received Jul 22, 2013 · Event occurred Jul 12, 2013
Report 1823260-2013-04403 · MDR key 3239280
Device
Generic name
Chemistry/micro Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04545885001
Lot number
NA
Product problems
- Melted
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
THE CUSTOMER ALLEGED THEY WERE HAVING REPEATED ISSUES WITH THE DRAWER OF THEIR LIGHTCYCLER 480 OPENING PROPERLY. THE CUSTOMER ALLEGED THE ISSUE CAUSED A PLATE TO MELT. THE CUSTOMER TRIED RE-INITIALIZING THE INSTRUMENT, PUTTING IN A PLATE, AND STARTING A RUN. THE CUSTOMER STATED THIS WORKED, BUT THE ISSUE HAPPENED OFF AND ON. THE CUSTOMER STATED THERE WERE NO REPORTS OF ANY INJURIES DUE TO THE MELTED PLATE. THERE WERE NO ADVERSE EVENTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE LIGHTCYCLER WAS MISADJUSTED. HE ADJUSTED THE LOADING, X AND Z. HE UPDATED THE LAMP AND DOOR ASSEMBLY. HE PERFORMED DIAGNOSTIC CHECKS FOR THE LAMP UNIT AND DRAWER LOADING. THE UNIT WAS OPERATING TO SPECIFICATION.
Additional Manufacturer Narrative
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. WHILE THIS DEVICE IS APPROVED FOR RESEARCH USE ONLY, IT IS LIKE OR SIMILAR TO THE COBAS 4800 SYSTEM COBAS Z 480 ANALYZER WHICH IS APPROVED FOR IN VITRO DIAGNOSTIC USE.
Additional Manufacturer Narrative
A ROOT CAUSE COULD NOT BE DETERMINED. THERE WAS NO INFORMATION AVAILABLE FOR AN INVESTIGATION PROVIDED BY THE CUSTOMER. IT WAS NOTED THE MULTIWELL PLATE EXPIRED ON 10/31/2007.