ONLINE TDM VALPROIC ACID

Additional Manufacturer Narrative

THE C501 MODULE SERIAL NUMBER WAS (B)(6) . THE CALIBRATION WAS LAST PERFORMED ON (B)(6) 2025, AND IT WAS ACCEPTABLE. QC WAS WITHIN THE RANGES ON THE DAY OF THE EVENT. THE ALARM TRACE DID NOT SHOW ANY ABNORMALITIES. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ONLINE TDM VALPROIC ACID (VALP2) ASSAY ON A COBAS 6000 C501 MODULE. INITIAL RESULT: 0.9 UG/ML (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: 88.4 UG/ML. THE 2ND REPEAT RESULT MATCHED THE 1ST REPEAT RESULT.

Additional Manufacturer Narrative

THE CUSTOMER ALLEGED DISCREPANT VALP2 RESULTS FOR AN ADDITIONAL PATIENT SAMPLE TESTED ON (B)(6) 2025: INITIAL RESULT: 0.4 UG/ML (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: 72.7 UG/ML. 2ND REPEAT RESULT: 75.3 UG/ML. THE FIELD SERVICE ENGINEER REPLACED THE SEALS ON THE REAGENT PIPETTE TRANSPORT MECHANISM, THE SAMPLE PIPETTE, AND 2 REAGENT PIPETTES. HE ALSO REPLACED THE SYRINGE MECHANISMS AND PIPES, INCLUDING THE DETERGENT RISER. THE PREVENTIVE MAINTENANCE WAS LAST PERFORMED IN FEB-2025. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

BASED ON THE PROVIDED DATA, A GENERAL LOT-SPECIFIC REAGENT ISSUE CAN BE EXCLUDED SINCE CALIBRATION AND QC WERE ACCEPTABLE. AFTER SEVERAL SERVICE ACTIONS WERE PERFORMED BY THE FIELD SERVICE ENGINEER, THE ANALYZER PERFORMED WITHIN SPECIFICATIONS FOR A MONTH, THEN THE ISSUE REOCCURRED. THE CUSTOMER COULD NOT PROVIDE ADDITIONAL PRE-ANALYTICAL DATA FOR FURTHER INVESTIGATION BECAUSE THE SAMPLES ARRIVED CENTRIFUGED AND COLLECTED IN A SECONDARY TUBE AT THE LABORATORY FOR PROCESSING. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS CONSISTENT WITH A PREANALYTIC ISSUE (SINCE THE RESULT IS ALMOST ZERO) AT THE CUSTOMER SITE. PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY.