inforMED
MalfunctionJFP

ABL 90 FLEX

Received Jan 7, 2011 · Event occurred Dec 8, 2010

Report 3002807968-2011-00001 · MDR key 1979805

Device

Generic name

Blood Gas Analyser

Model number

SC90 -600 TESTS

Catalog number

946-008

Lot number

R0031

Product problems

  • Incorrect Or Inadequate Test Results
  • Device Operates Differently Than Expected

Patient

Not reported

  • No Information

Narrative

Additional Manufacturer Narrative

DATA ANALYSIS FROM THE INSTRUMENT SHOWS THAT THE MALFUNCTION WAS CAUSED BY A BIAS ON THE REFERENCE ELECTRODE IN THE SC, WHICH WAS QUICKLY BUILT UP AFTER INSTALLATION OF THE SC. THE FAILING SENSOR CASSETTE WAS RETRIEVED FROM THE CUSTOMER SITE AND IS CURRENTLY BEING TESTED IN R&D. ONCE THE INVESTIGATION IS COMPLETED, THE RESULTS WILL BE SUBMITTED IN A F/U REPORT.

Description of Event or Problem

THE ANALYZER YIELDED FALSE PT RESULTS FOR BLOOD MEASUREMENTS BECAUSE OF A MALFUNCTIONING SENSOR CASSETTE. A COMPARISON OF PT DATA FROM THIS INSTRUMENT AND ANOTHER ABL90 SHOWED A BIAS OF -9 MMOL FOR SODIUM, -0.1 MMOL FOR CALCIUM, -0.2 MMOL FOR POTASSIUM, +0.018 FOR PH AND +7 MMOL FOR CHLORIDE.