ALBT2 TINA-QUANT ALBUMIN GEN.2

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER CHECKED PROBE ALIGNMENTS AND PUMP PRESSURES. THE GEAR PUMP AND WASH PUMP PRESSURES WERE ADJUSTED. THE MICROALBUMIN TEST WAS CALIBRATED AND PRECISION STUDIES WERE PERFORMED; RESULTS WERE WITHIN SPECIFICATION. THE CUSTOMER REPEATED THE SAMPLES IN QUESTION AND RESULTS MEASURED WITH THE NEW LOT OF REAGENT WERE VERY CLOSE, BUT THESE DID NOT MATCH THE RESULTS OBTAINED WITH THE OLD LOT. THE LAST CALIBRATION PERFORMED ON (B)(6) 2021 WITH LOT 515982 WAS NOT OK AND HAD AN ERROR. QUALITY CONTROLS WERE OUTSIDE OF RANGE FOR REAGENT LOT 515982. THE CUSTOMER CONFIRMED THE ASSAY IS NOW WORKING AS EXPECTED AFTER THE SERVICE ACTIONS AND A DIFFERENT REAGENT LOT WAS INSTALLED. THE INVESTIGATION DETERMINED THE ISSUE WAS RESOLVED BY THESE ACTIONS. MEDWATCH FIELD UDI NUMBER (B)(4).

Description of Event or Problem

THE INITIAL REPORTER STATED THEY STARTED USING A NEW LOT NUMBER OF ALBT2 TINA-QUANT ALBUMIN GEN.2 (MICROALBUMIN, LOT 51598201, EXPIRATION DATE = 31-AUG-2022) ON THE COBAS 6000 C (501) MODULE AND HAD MULTIPLE FAILED CALIBRATION ATTEMPTS. CALIBRATION THEN WAS SUCCESSFUL, BUT CONTROLS WERE OUTSIDE OF RANGE. THE CUSTOMER PULLED PATIENT URINE SAMPLES THAT WERE INITIALLY TESTED USING OLD MICROALBUMIN REAGENT LOT 497736 (EXPIRATION DATE UNKNOWN) AND THEN TESTED THESE USING THE NEW LOT 51598201. A NEW SHIPMENT OF NEW LOT 51598201 WAS SENT TO THE CUSTOMER AND CALIBRATION AND CONTROLS TESTED WITH THIS REAGENT PASSED. THE PATIENT URINE SAMPLES WERE ALSO TESTED USING THIS NEW SHIPMENT. THERE WERE DISCREPANCIES IN THE RESULTS FOR SIX PATIENT SAMPLES. ALL INITIAL RESULTS MEASURED WITH THE OLD LOT NUMBER WERE REPORTED OUTSIDE OF THE LABORATORY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SERIAL NUMBER OF THE C 501 ANALYZER IS (B)(4).