ALBT2 TINA-QUANT ALBUMIN GEN.2

Additional Manufacturer Narrative

THE C502 MODULE SERIAL NUMBER WAS (B)(6). ERRORS WERE OBSERVED DURING A REVIEW OF THE CALIBRATION TRACE DATA. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL DATA OR INFORMATION FOR INVESTIGATION. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENT URINE SAMPLES TESTED FOR ALBT2 TINA-QUANT ALBUMIN GEN.2 (ALBT2) ON A COBAS 8000 C 502 MODULE. PATIENT 1 INITIAL RESULT WAS 27.3 MG/L. THE REPEAT RESULT WAS 0.5 MG/L. PATIENT 2 INITIAL RESULT WAS 191.3 MG/L. THE REPEAT RESULT WAS 12.0 MG/L. IT IS NOT KNOWN WHICH RESULTS WERE BELIEVED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.