ALTL ALANINE AMINOTRANSFERASE - PYRIDOXAL PHOPHATE ACTIVATED

Additional Manufacturer Narrative

THE EVENT OCCURRED IN: (B)(6).

Description of Event or Problem

THE CUSTOMER ORIGINALLY COMPLAINED ABOUT QUESTIONABLE CREP2 CREATININE PLUS VER.2 TESTED ON BOTH A COBAS 6000 C (501) MODULE AND A COBAS 8000 (UNSPECIFIED MODULE) COMPARED TO AN ABBOTT SYSTEM. FROM THE DATA PROVIDED, A REPORTABLE MALFUNCTION WAS PROVIDED FOR CREP2, ASTLP ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION, ALTLP ALANINE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION, AND GGT-2 -GLUTAMYLTRANSFERASE VER.2 STANDARDIZED AGAINST IFCC / SZASZ. THIS MEDWATCH WILL COVER ALTLP. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON ASTLP. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON GGT-2. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON CREP2. THE ERRONEOUS RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. THE PATIENT WAS SENT TO THE HOSPITAL DUE THE INITIAL HIGH CREP2 RESULT, BUT THERE WAS NO ALLEGATION THAT THE PATIENT WAS ADVERSELY AFFECTED. THE COBAS C501 SERIAL (B)(4). THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC INFORMATION ON THE COBAS 8000 SYSTEM. A PRELIMINARY ASSESSMENT OF THE CASE STATED THAT BASED ON PREVIOUS ELECTROPHORESIS TESTING OF THE PATIENT, THE PATIENT IS BELIEVED TO HAVE AN INTERFERING FACTOR PRESENT. THE INVESTIGATION IS CURRENTLY ONGOING.

Additional Manufacturer Narrative

THE CUSTOMER'S COBAS 8000 MODEL USED WAS A C701. THE PATIENT SAMPLE WAS RECEIVED FOR FURTHER INVESTIGATION. THE RESULTS FROM THE INVESTIGATION HAVE RESULTS INDICATIVE OF A MONOCLONAL GAMMOPATHY. CLARIFICATION WAS REQUESTED IF THIS INTERFERENCE COULD HAVE CAUSED THE DISCREPANT RESULTS OBSERVED BUT CLARIFICATION WAS NOT PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.