TINA-QUANT ALBUMIN GEN.2

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER BUT DID NOT FIND AN ISSUE. HE EXAMINED THE FLUIDICS SYSTEM, PERFORMED INSTRUMENT CHECKS, AND PERFORMED PRECISION TESTING THAT RECOVERED WITHIN GUIDELINES. AS THE CUSTOMER WAS UNABLE TO PROVIDE FURTHER INFORMATION, THE INVESTIGATION WAS UNABLE TO DEFINE A SPECIFIC ROOT CAUSE.

Additional Manufacturer Narrative

THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 (MICROALBUMIN) RESULTS FOR A URINE SAMPLE FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT 2.94 MG/DL (29.4 MG/L) WITH AN INVALIDATING DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED AND THE RESULT WAS 1.64 MG/DL (16.4 MG/L) WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH A 1:3 DILUTION AND THE RESULT WAS 2.71 MG/DL (27.1 MG/L) WITH A DATA FLAG. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE FINAL REPEAT RESULT WAS BELIEVED TO BE CORRECT.