inforMED
MalfunctionFIP

ELIX

Received May 12, 2015 · Event occurred May 6, 2015

Report 4780577 · MDR key 4780577

Device

Generic name

Purifier, Water (absorption, Deionization, Membrane Filter,

Model 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.