ABL 800FLEX

Description of Event or Problem

WHILE MEASURING BLOOD SAMPLES ON THE BLOOD GAS ANALYZERS ABL 837, WITH CREATININE MODULES, ERRONEOUS VALUES FOR PH AND ELECTROLYTES WERE OBTAINED AFTER A PERIOD OF TWO WEEKS. COMPARISON MEASUREMENTS ON VITROS CHEMISTRY ANALYZER OVER A TWO WEEK PERIOD CONFIRMED THIS. SCHEDULED CALIBRATIONS AND QCS DID NOT TRIGGER ANY ALARMS. THE HOSPITAL INTRODUCED A NEW PROCEDURE WHERE THEY REPLACED THE REFERENCE MEMBRANE AFTER 2 WEEKS AND THIS SOLVED THE PROBLEMS OF ERRONEOUS VALUES FOR PH AND ELECTROLYTES. THERE HAVE BEEN NO ALLEGATIONS OF DEATH OR SERIOUS INJURY.

Additional Manufacturer Narrative

THE EVALUATION PERFORMED CONSISTED OF ANALYSIS OF DATA PROVIDED BY CUSTOMER. CONCLUSION OF EVALUATION: REFERENCE MEMBRANE IN CREA INSTRUMENTS ARE DAMAGED DUE TO PROLONGED EXPOSURE TO FLUIDS, RESULTING IN DEVICES PERFORMING OUTSIDE ANALYTICAL SPECIFICATIONS. REPLACEMENT INTERVALS RECOMMENDED IN LABELING IS TO BE CHANGED TO THE FOLLOWING: FOR AN AVERAGE OF 40 SAMPLES OR LESS PER DAY, REPLACE REFERENCE MEMBRANE AFTER 2 WEEKS. FOR AN AVERAGE ABOVE 40 SAMPLES PER DAY, REPLACE REFERENCE MEMBRANE AFTER ONE WEEK. WHEN THE REFERENCE MEMBRANE IS REPLACED ACCORDING TO THE SCHEDULE ABOVE OPPOSED TO AFTER A MONTH, AS RECOMMENDED IN THE LABELING, THE MEMBRANE THEN PERFORMS ACCORDING TO SPECIFICATIONS.