ALANINE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION

Additional Manufacturer Narrative

THE FIELD SERVICE REPRESENTATIVE NOTED THAT DIFFERENT MODULES IN THE LABORATORY HAD SIMILAR ISSUES, AND THAT SAMPLES WITH VALUES BELOW 12 U/L OFTEN REPEATED WITH RESULTS OF <5 U/L WITH NEGATIVE VALUES. AS THE ISSUE AFFECTS DIFFERENT MODULES, THE EVENT IS CONSISTENT WITH A PREANALYTICAL HANDLING ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. BASED ON THE INFORMATION PROVIDED, THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ALANINE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULT WAS <5 U/L, AND THE REPEATED RESULT WAS 33 U/L.