ELIX
Received May 12, 2015 · Event occurred May 6, 2015
Report 4780577 · MDR key 4780577
Device
Generic name
Purifier, Water (absorption, Deionization, Membrane Filter,
Manufacturer
Emd Millipore CorporationModel number
ELIX 100 (CUSTOM)Catalog number
PROGTLOS1US
Lot number
F3MA66536
Product problems
- Incorrect Or Inadequate Test Results
- Environmental Compatibility Problem
Patient
*
- No Patient Involvement
Narrative
Description of Event or Problem
BEGINNING WITH THE START UP IN THE AM FOR MIDNIGHT SHIFT, WE STARTED HAVING QC ISSUES WITH CALCIUMS ON THE CE TO THE POINT WE COULD NOT GET THE QC TO WORK AT ALL. ROCHE HOTLINE WAS CONTACTED AND MULTIPLE PROCEDURES (CLEANS, FLUSHES, RECAL'S, REAGENT DUMPS, ETC.) WERE TRIED. NOTHING FIXED IT. WHEN DAY SHIFT ATTEMPTED THEIR START UP ON THE OTHER ANALYZER (CEE), WE EXPERIENCED THE SAME ISSUE. WHEN WE CALLED SERVICE, WE WERE TOLD THAT THE WATER COMING INTO THE ANALYZERS COULD BE A POTENTIAL CAUSE FOR THE PROBLEM. SERVICE DID COME IN AND DUMPED AND CLEANED THE WATER BATH ON THE CEE, AND CHECKED FOR ANYTHING ON THE INSTRUMENT THAT COULD HAVE CAUSED THE ISSUE. BUT WITH THE PROBLEM OCCURRING ON BOTH ANALYZERS, WE FELT STRONGLY IT WAS THE WATER THAT HAD CAUSED THE PROBLEMS. WE HAD TO DUMP ALL CALCIUM PACKS THAT HAD BEEN LOADED DURING THAT TIME, AS THEY ALL HAD USED WATER FOR DILUTING REAGENTS. BY THE END OF DAY, WE WERE FINALLY ABLE TO GET QC TO WORK AND START REPORTING PTS AGAIN.