TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATION

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER (FSE) CHECKED THE PUMP PRESSURE, WATER PUMP, GEAR PUMP, AND VALVES. ALL WERE OPERATING WITH NO ISSUES. THE FSE PERFORMED SUCCESSFUL CALIBRATION, HARDWARE CHECKS, AND PRECISION. THE INSTRUMENT PERFORMANCE WAS VERIFIED. NO FURTHER ISSUES WERE REPORTED SINCE THE SERVICE VISIT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. MEDWATCH FIELDS D1, D2, D4, G1, AND G4 HAVE BEEN UPDATED.

Additional Manufacturer Narrative

THE REAGENT LOT NUMBER WAS 845956. THE EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ALBT2 TINA-QUANT ALBUMIN GEN.2 FOR URINE SAMPLES FROM ONE PATIENT USING A COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS <12 MG/L WITH A DATA FLAG. THE FIRST REPEAT RESULT WAS 143 MG/L. THE SECOND AND THIRD REPEAT RESULTS WERE 44 MG/L AND 83 MG/L. THE FIRST REPEAT RESULT WAS QUESTIONED AS IT WAS CONSIDERED TOO HIGH WHICH TRIGGERED THE FURTHER REPEAT TESTING OF THE SAMPLE. NONE OF THE RESULTS WERE REPORTED OUT. IT IS UNKNOWN WHICH RESULTS WERE DEEMED CORRECT.