LACTATE DEHYDROGENASE ACC. IFCC VER.2

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS C 503 ANALYTICAL UNIT IS (B)(6). THE INVESTIGATION REVIEWED THE CALIBRATIONS PERFORMED FROM (B)(6) 2023 TO (B)(6) 2024 AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE QC RECOVERY FROM (B)(6) 2023 TO (B)(6) 2024 ; THE QC RECOVERY WAS WITHIN THE +/- 2 STANDARD DEVIATION RANGE AND WAS WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE REACTION MONITOR AND NO ISSUES WERE NOTED. THE INVESTIGATION REVIEWED THE CUSTOMER'S HANDLING OF PATIENT SAMPLES. THE TARGET VOLUME WAS 6 ML AND THE SAMPLE DRAW VOLUME WAS 3 ML. THE CUSTOMER STATED THAT OTHER PATIENT SAMPLES HAD PROPER DRAW VOLUMES. THE PATIENT SAMPLE WAS INVERTED 4 TIMES AND THE CLOTTING TIME WAS 15 TO 30 MINUTES. THE PATIENT SAMPLE WAS CENTRIFUGED FOR 10 MINUTES AT 3500 RPM. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE LDHI2 LACTATE DEHYDROGENASE VER.2 RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE REPORTER WAS ABLE TO PROVIDE ONE PATIENT SAMPLE WITH DISCREPANT RESULTS: THE INITIAL RESULT WITH THE PATIENT SAMPLE IN THE PRIMARY TUBE WAS 217 IU/L. THE REPEAT RESULT WITH THE PATIENT SAMPLE IN A HITACHI CUP WAS 150 IU/L.

Additional Manufacturer Narrative

THE INVESTIGATION CONFIRMED THAT THE PATIENT SAMPLE TUBE WAS CORRECTLY FILLED. THE INVESTIGATION DETERMINED THAT THE CUSTOMER'S NUMBER OF PATIENT SAMPLE TUBE INVERSIONS (FOUR) SEEMED TO BE INSUFFICIENT. THE INVESTIGATION REVIEWED THE ALARM TRACE. ON (B)(6) 2024, MULTIPLE "SAMPLE FOAM DETECTION" ALARMS AND AN "ABNORMAL CELL BLANK DIFFERENCE" WERE NOTED. THE INVESTIGATION RULED OUT A GENERAL REAGENT PROBLEM BECAUSE CALIBRATION AND QC WERE ACCEPTABLE. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A PREANALYTIC ISSUE AT THE CUSTOMER SITE (MULTIPLE "SAMPLE FOAM DETECTION" ALARMS IN THE ALARM TRACE). PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.