ALBT2

Additional Manufacturer Narrative

THE INVESTIGATION REVIEWED THE PROVIDED QC AND NO ABNORMALITIES WERE FOUND. THE INVESTIGATION REVIEWED THE SYSTEM ALARM TRACE AND FOUND "SAMPLE ASPIRATION" ALARMS. THE PATIENT'S SAMPLE WAS PROVIDED FOR AN INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE URINE ALBT2 TINA-QUANT ALBUMIN GEN.2 (MICROALBUMIN) RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 C 502 MODULE WITH SERIAL NUMBER (B)(4). THE PATIENT'S INITIAL MICROALBUMIN RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S DOCTOR DID NOT BELIEVE THE REPORTED MICROALBUMIN RESULT. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE PATIENT'S SAMPLE ON THE C 502 MODULE AND AN OPTILITE ANALYZER. ON (B)(6) 2022, THE PATIENT'S INITIAL MICROALBUMIN RESULT WAS 0.247 G/L. ON (B)(6) 2022, THE PATIENT'S MICROALBUMIN RESULT ON THE OPTILITE ANALYZER WAS 6.8 G/L. ON (B)(6) 2022, THE PATIENT'S REPEAT MICROALBUMIN RESULT WAS 0.223 G/L. THIS RESULT WAS REPORTED TO THE PATIENT'S DOCTOR. ON (B)(6) 2022, THE PATIENT'S REPEAT MICROALBUMIN RESULT WITH A 1:11 DILUTION WAS 6.277 G/L WITH A DATA FLAG. ON (B)(6) 2022, THE PATIENT'S REPEAT MICROALBUMIN RESULT WITH A 1:50 DILUTION WAS 6.879 G/L. THE CUSTOMER DETERMINED THE CORRECT RESULTS FOR THE PATIENT WERE 6.8 G/L, 6.277 G/L, AND 6.879 G/L.

Additional Manufacturer Narrative

THE INVESTIGATION COULD NOT REPRODUCE THE CUSTOMER'S RESULTS. THE INVESTIGATION TESTED THE PATIENT'S SAMPLE WITHOUT DILUTION AND A VALID ALBUMIN RESULT COULD NOT BE PRODUCED DUE TO A DATA FLAG. THE INVESTIGATION TESTED THE PATIENT'S SAMPLE WITH A 1:11 (DECREASED MODE) AND A 1:10 DILUTION AND THE ALBUMIN RESULTS WERE 5207.6 MG/L WITH A DATA FLAG AND 5385.9 MG/L WITH A DATA FLAG. THE INVESTIGATION TESTED THE PATIENT'S SAMPLE WITH A 1:20 AND A 1:50 DILUTION, AND THE PATIENT'S RESULTS WERE 5190.7 MG/L AND 4680.0 MG/L, WHICH WERE COMPARABLE WITH THE MEASUREMENT OF THE OPTILITE ANALYZER. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.