ABL 800FLEX

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.

Description of Event or Problem

WHILE MEASURING BLOOD SAMPLES ON THE BLOOD GAS ANALYZERS ABL 827 WITH CREATININE MODULES, DRIFTS IN THE ANION GAPS VALUES WERE OBTAINED OVER A PERIOD OF TWO WEEKS. THE ANION GAP IS A CALCULATED MEASUREMENT FOR THE CONCENTRATION OF POSITIVE AND NEGATIVE IONS IN A BLOOD SAMPLE. THIS CALCULATION REFERS TO MEASUREMENTS OF THE ELECTROLYTES AND PH. SCHEDULED CALIBRATIONS AND QCS DID NOT TRIGGER ANY ALARMS. THE REFERENCE MEMBRANE WAS REPLACED AND THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. AFTER A PERIOD OF 2 WEEKS, THE ERROR IN THE ANION GAP RE-OCCURRED AND THE REFERENCE MEMBRANE WAS REPLACED AGAIN, SOLVING THE PROBLEM. THERE HAVE BEEN NO ALLEGATIONS OF DEATH OR INJURY.