AST

Additional Manufacturer Narrative

THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

TESTING OF THE RETURNED PATIENT SAMPLE CONFIRMED THE CUSTOMER'S RESULTS. THE INVESTIGATION DID NOT CONFIRM AN INTERFERENCE WITH THE MEDICATION MONOFER. AS QUALITY CONTROLS WERE ACCEPTABLE, A GENERAL REAGENT ISSUE COULD BE EXCLUDED.

Additional Manufacturer Narrative

SAMPLE FROM THE PATIENT WAS REQUESTED FOR FURTHER INVESTIGATION. THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ALTL ALANINE AMINOTRANSFERASE AND ASTLP ASPARTATE AMINOTRANSFERASE RESULTS FOR ONE PATIENT FROM COBAS 6000 SERIES SYSTEM SERIAL NUMBER (B)(4). THE CUSTOMER SUSPECTED AN INTERFERENCE WITH THE MEDICATION "MONOFER" (IRON SUPPLEMENT). THIS MEDWATCH IS FOR ASTLP. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE ALTL ASSAY. THE INITIAL RESULTS WERE A "NORMAL SAMPLE RUN". NO SPECIFIC DATA WAS PROVIDED. THE REPEAT RESULTS WITH A 1:10 DILUTION WERE: ALTLP: 9 I/U WITH A DATA FLAG AND 4 I/U WITH A DATA FLAG. ASTLP: 12 I/U WITH A DATA FLAG AND 29 I/U WITH A DATA FLAG. THE REPEAT RESULTS WERE A 1:20 DILUTION WERE: ALTLP: 7 I/U WITH A DATA FLAG. ASTLP: 13 I/U WITH A DATA FLAG. THE REPEAT RESULTS WERE: ALTLP: 4 I/U WITH A DATA FLAG. ASTLP: -13 I/U WITH A DATA FLAG. AFTER THE SAMPLE WAS RECENTRIFUGED, THE RESULTS WERE: ALTLP: 8 I/U WITH A DATA FLAG AND 10 I/U WITH A DATA FLAG. ASTLP: 14 I/U WITH A DATA FLAG AND 31 I/U WITH A DATA FLAG. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.