ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT C-REACTIVE PROTEIN IV (CRP), TOTAL PROTEIN GEN.2 (TP), AND ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP) RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER ALP. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CRP RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TP RESULTS. THE CUSTOMER WAS PROMPTED TO REPEAT THE PATIENT SAMPLES AS THEY LOOKED LIKE THEY HAD NOT BEEN CENTRIFUGED. SAMPLE 1 HAD AN INITIAL CRP RESULT OF 0.362 MG/DL AND AN INITIAL TP RESULT OF 10.6 G/DL. THE REPEAT CRP RESULT WAS 0.62 MG/DL AND THE REPEAT TP RESULT WAS 7.0 G/DL. SAMPLE 2 HAD AN INITIAL ALP RESULT OF 159 U/L. THE REPEAT RESULT WAS 88 U/L. THE REPEAT RESULTS WERE DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

Additional Manufacturer Narrative

CALIBRATION WAS LAST PERFORMED ON (B)(6) 2025. THE ALARM TRACE DID NOT CONTAIN A CONSPICUOUS EVENT. IT WAS DETERMINED THAT THE SAMPLES WERE NOT CENTRIFUGED BEFORE BEING TESTED. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH PRE-ANALYTICAL SAMPLE HANDLING ISSUES.