ALBT2 TINA-QUANT ALBUMIN GEN.2

Additional Manufacturer Narrative

THE FOLLOWING CLARIFICATIONS WERE PROVIDED: THE INITIAL AND RERUN TESTS WERE PERFORMED FROM THE SAME SAMPLE VIAL. 12 MM X 75 MM RIA TUBES WERE USED FOR URINE SAMPLE.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE 24 HOUR URINE PATIENT SAMPLE TESTED FOR ALBT2 TINA-QUANT ALBUMIN GEN.2 ON A COBAS INTEGRA 400 PLUS (I400+). THE SAMPLE INITIALLY RESULTED WITH AN ALBT2 VALUE OF 144.182 MG/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. THE PATIENT QUESTIONED THE RESULT SINCE IT WAS ELEVATED AND A PHYSICIAN ASKED FOR A REPEAT OF THE SAMPLE. THE SAMPLE WAS REPEATED ON (B)(6) 2018, RESULTING AS 148.331 MG/L. THE SAMPLE WAS DILUTED (DILUTION FACTOR UNKNOWN) AND REPEATED FIVE MORE TIMES ON (B)(6) 2018, RESULTING AS 1234.98 MG/L, 1283.99 MG/L, 1278.84 MG/L, 1295.05 MG/L, AND 1270.67 MG/L. THE SAMPLE WAS DILUTED 1:10 AND REPEATED ON (B)(6) 2018, RESULTING AS 1301.479 MG/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBER OF THE I400+ WAS (B)(4).

Additional Manufacturer Narrative

THE CALIBRATION DATA SHOWS FEW CALIBRATIONS AND SOME CALIBRATION FAILURES. THE REASON FOR THE CALIBRATION FAILURES IS UNKNOWN. QC RECOVERY WAS ACCEPTABLE AND DOES NOT INDICATE AN ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.