ALTP GEN.2

Additional Manufacturer Narrative

THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION. THE FIELD SERVICE ENGINEER (FSE) DID NOT IDENTIFY A CAUSE FOR THE EVENT. THE FIELD APPLICATION SPECIALIST (FAS) PERFORMED PRECISION TESTING AND RESULTS WERE WELL WITHIN THEIR ESTABLISHED RANGE. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE INSTRUMENT'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ALTP GEN.2 RESULTS FOR 2 PATIENT SAMPLES AND QUESTIONABLE LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. ALTP RESULTS: PATIENT 1: THE INITIAL RESULT WAS 54 U/L. THE RESULT WITH THE NEW REAGENT LOT WAS 95 U/L. THE REPEATED RESULT WITH THE INITIAL REAGENT LOT WAS 114 U/L. PATIENT 2: THE INITIAL RESULT WAS 236 U/L. THE RESULT WITH THE NEW REAGENT LOT WAS 427 U/L. THE REPEATED RESULT WITH THE INITIAL REAGENT LOT WAS 429 U/L. LDH RESULTS: PATIENT 3: ON (B)(6) 2024, THE INITIAL RESULT WAS 885 U/L. THE RESULT WITH THE NEW REAGENT LOT WAS 518 U/L. THE REPEATED RESULT WITH THE INITIAL REAGENT LOT WAS 564 U/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED A LOT-TO-LOT COMPARISON STUDY WITH THE ALLEGED SAMPLES USING NEW REAGENT LOTS. THE CUSTOMER NOTICED THE DISCREPANCIES AND REPEATED THE SAMPLES ON ANOTHER MODULE USING THE SAME REAGENT LOTS THAT WERE USED TO OBTAIN THE INITIAL RESULTS. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT AS THEY WERE COMPARABLE WITH THE RESULTS OBTAINED DURING THE LOT-TO-LOT COMPARISON. THIS MEDWATCH WILL APPLY TO THE ALTP GEN.2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE LACTATE DEHYDROGENASE ACC. IFCC VER.2 ASSAY.