ABL 800FLEX

Additional Manufacturer Narrative

THE EVALUATION PERFORMED CONSISTED OF ANALYSIS OF DATA PROVIDED BY CUSTOMER. THE REFERENCE MEMBRANE WAS RETURNED TO MANUFACTURER AND EVALUATED. 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.

Description of Event or Problem

WHILE MEASURING BLOOD SAMPLES ON THE BLOOD GAS ANALYZERS ABL 827S, WITH CREATININE MODULES, LOW VALUES WERE OBTAINED FOR PH AND ELECTROLYTES. COMPARISON MEASUREMENTS ON OTHER ABL MODELS AND ROCHE INSTRUMENTS CONFIRMED THE LOW VALUES. SCHEDULED AND MANUAL CALIBRATIONS AND QCS WERE PERFORMED WITHOUT TRIGGERING ANY ALARMS. THE REFERENCE MEMBRANE WAS REPLACED AND THE DEVICE THEN PERFORMED ACCORDING TO SPECIFICATIONS. THERE HAVE NOT BEEN ANY ALLEGATIONS OF DEATH OR INJURY.