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 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP) RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 COBAS C 502 MODULE. THIS MEDWATCH WILL COVER ALP. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CALCIUM RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LACTATE RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LDH RESULTS, AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE AST RESULTS. THE DOCTOR QUESTIONED THE RESULTS AS THEY WERE HIGH AND DID NOT MATCH THE CLINICAL STATUS OF OUTPATIENTS IN "NORMAL" CONDITION. NO SPECIFIC SAMPLE RESULTS WERE PROVIDED.

Additional Manufacturer Narrative

THE CALIBRATION RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION. THE QC RECOVERY DATA FOR THE AFFECTED ASSAYS WAS HIGH BUT WITHIN THE CUSTOMER'S ESTABLISHED RANGES. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER. NEW ROCHE QC WAS ORDERED AND PERFORMED BY THE CUSTOMER WITH ADJUSTED MEANS. QC WAS PERFORMED WITHIN SPECIFICATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.