IMMULITE 2000 XPI THYROGLOBULIN (TG)

Description of Event or Problem

THE CUSTOMER OBSERVED A DEPRESSED IMMULITE 2000 XPI THYROGLOBULIN (TG) RESULT FOR A PATIENT SAMPLE COMPARED TO THE REPEAT RESULT WITH THE SAME REAGENT LOT ON A DIFFERENT DAY. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DEPRESSED IMMULITE 2000 XPI TG RESULT.

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATES CUSTOMER OBSERVED A DEPRESSED IMMULITE 2000 XPI THYROGLOBULIN (TG) RESULT FOR A PATIENT SAMPLE COMPARED TO THE REPEAT RESULT WITH THE SAME REAGENT LOT ON A DIFFERENT DAY. THE CUSTOMER WAS PERFORMING A LOT TO LOT METHOD COMPARISON WITH NEW LOTS OF REAGENT WHEN THEY NOTED THE INITIAL RESULT GENERATED WITH LOT 427 WAS DEPRESSED COMPARED TO THE REPEAT RESULT WITH LOT 427 WHICH THE CUSTOMER CONSIDERED CORRECT. IT IS UNKNOWN HOW THE SAMPLE WAS STORED BETWEEN THE INITIAL AND REPEAT TESTING. SIEMENS IS INVESTIGATING. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD ALWAYS BE USED IN COMBINATION WITH THE CLINICAL EXAMINATION, PATIENT MEDICAL HISTORY, AND OTHER FINDINGS."

Additional Manufacturer Narrative

THE INITIAL MDR 1219913-2022-00162 WAS FILED ON MAY 31, 2022. ADDITIONAL INFORMATION - JULY 18, 2022: AN OUTSIDE THE UNITED STATES CUSTOMER OBSERVED A DEPRESSED IMMULITE 2000 XPI THYROGLOBULIN (TG) RESULT FOR A PATIENT SAMPLE COMPARED TO THE REPEAT RESULT WITH THE SAME REAGENT LOT ON A DIFFERENT DAY. THE CUSTOMER WAS PERFORMING A LOT TO LOT METHOD COMPARISON WITH NEW LOTS OF REAGENT WHEN THEY NOTED THE INITIAL RESULT GENERATED WITH LOT 427 WAS DEPRESSED COMPARED TO THE REPEAT RESULT WITH LOT 427 WHICH THE CUSTOMER CONSIDERED CORRECT. INITIALLY, IT WAS UNKNOWN HOW THE SAMPLE WAS STORED BETWEEN THE INITIAL AND REPEAT TESTING. THE CUSTOMER CONFIRMED THAT THE PATIENT SAMPLE WAS STORED IN A -20C FREEZER. SIEMENS CONTINUES TO INVESTIGATE.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2022-00162 ON MAY 31, 2022. SIEMENS FILED THE MDR 1219913-2022-00162 SUPPLEMENTAL REPORT 1 ON AUG 12, 2022. OCT 05, 2022 ADDITIONAL INFORMATION: AN OUTSIDE THE UNITED STATES CUSTOMER OBSERVED IMPRECISION ON A PATIENT SAMPLE WITH IMMULITE 2000 THYROGLOBULIN (TG) KIT LOT 427, DURING LOT TO LOT COMPARISONS. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER IN ORDER TO INVESTIGATE, BUT IT WAS NOT RECEIVED. THE CUSTOMER STOPPED RUNNING THE TG ASSAY ON THE IMMULITE 2000 SYSTEM AND REQUIRES NO FURTHER SUPPORT ON THIS COMPLAINT. IN SECTION H6, THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED.