ALBT2 TINA-QUANT ALBUMIN GEN.2

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). (B)(4).

Description of Event or Problem

THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED FOR ALBT2 TINA-QUANT ALBUMIN GEN.2 (ALB) ON A COBAS INTEGRA 400 PLUS (I400+) AT THE CUSTOMER LABORATORY AND A COBAS 6000 C (501) MODULE - C501 AT A SECOND LABORATORY. THE FIRST SAMPLE FROM THE PATIENT WAS TESTED ON THE CUSTOMER'S I400+ ANALYZER AND RESULTED AS "BETWEEN 18 AND 20" G/L. THE PATIENT WENT TO THE HOSPITAL WHERE THE ALB ON A SIEMENS INSTRUMENT WAS 36 G/L. THE DOCTOR BELIEVED THE 36 G/L RESULT WAS CORRECT, AND STATED THE RESULT FROM THE I400+ ANALYZER WAS TOO LOW. THE FIRST SAMPLE WAS SENT TO A SECOND LABORATORY, AND THE ALB WAS 18 G/L WHEN MEASURED ON A C501 ANALYZER. THE ROCHE ALB METHOD IS AN IMMUNOTURBIDIMETRIC METHOD, WHEREAS THE SIEMENS METHOD IS A BROMOCRESOL METHOD. THE DIFFERENCE IN RESULTS WAS BELIEVED TO BE RELATED TO THE DIFFERENCE IN METHODOLOGY. A REAGENT CASSETTE OF THE ROCHE BROMOCRESOL ALB METHOD WAS SENT TO THE CUSTOMER FOR TROUBLESHOOTING. A SECOND SAMPLE FROM THE PATIENT WAS THEN TESTED ON THE I400+ USING BOTH METHODS ON (B)(6) 2017. THE RESULT FROM THE IMMUNOTURBIDIMETRIC METHOD WAS 20.8 G/L AND THE RESULT FROM THE ROCHE BROMOCRESOL ALB METHOD WAS 30.8 G/L. NO ADVERSE EVENTS WERE ALLEGED. THE SERIAL NUMBERS OF THE I400+ AND C501 ANALYZERS THAT WERE USED WERE REQUESTED BUT NOT PROVIDED.

Additional Manufacturer Narrative

THE BROMOCRESOL ALB METHOD IS LESS SPECIFIC THAN THE ROCHE IMMUNOTURBIDIMETRIC ALB METHOD (COMPLAINED ASSAY), SO THE BROMOCRESOL METHOD CAN GIVE HIGHER RESULTS.

Additional Manufacturer Narrative

QUALITY CONTROL RECOVERY WAS OF VERY HIGH QUALITY, PRECISE, AND ACCURATE. GAMMOPATHY INTERFERENCE CAN NOT BE COMPLETELY EXCLUDED, BUT BASED ON THE DILUTION EXPERIMENTS, NO INDICATION FOR INTERFERENCE WAS FOUND. THE COMPLAINED ALB REAGENT IS HIGHLY SPECIFIC AND CAN THEREFORE GIVE LOWER RESULTS THAN OTHER METHODS.

Additional Manufacturer Narrative

SAMPLES FROM THE PATIENT WERE PROVIDED FOR INVESTIGATION. THE VALUES OBTAINED BY THE CUSTOMER WERE DUPLICATED. DILUTION OF THE SAMPLES DID NOT CHANGE THE RESULTS, SO IT IS UNLIKELY THAT AN INTERFERENT TO THE ALB ASSAY IS PRESENT IN THE SAMPLES.