IMMULITE 2000 CALCITONIN

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR ON NOVEMBER 19, 2021. DECEMBER 22, 2021 ADDITIONAL INFORMATION: A US CUSTOMER OBSERVED DEPRESSED IMMULITE 2000 CALCITONIN RESULT FOR A PATIENT SAMPLE COMPARED TO REPEAT TESTING FROM DIFFERENT LOT NUMBER. SIEMENS REQUESTED THE INSTRUMENT FILES FOR THE DAY OF THE EVENT AND THE DAY BEFORE THE EVENT TO FURTHER INVESTIGATE. THE CUSTOMER SERVICE ENGINEER (CSE) WAS UNABLE TO PROVIDE THE REQUESTED FILES AS THE SYSTEM IS BEING REPLACED WITH A NEWER SYSTEM. SIEMENS IS UNABLE TO DEFINITIVELY DETERMINE THE CAUSE OF THE DISCORDANT RESULT HOWEVER PRE-ANALYTICAL FACTORS CANNOT BE RULE OUT. SIEMENS REVIEWED IN HOUSE KIT RELEASE FOR LOTS 317 AND 319. BOTH KIT LOTS MET ALL MANUFACTURES REQUIREMENTS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem

CUSTOMER OBSERVED A DEPRESSED IMMULITE 2000 CALCITONIN RESULT FROM A SAMPLE THAT WAS CONSIDERED DISCORDANT WITH THE REPEAT RESULT TESTED WITH A DIFFERENT REAGENT LOT NUMBER. THE DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CALCITONIN RESULT.

Additional Manufacturer Narrative

A US CUSTOMER OBSERVED DEPRESSED IMMULITE 2000 CALCITONIN RESULT FOR A PATIENT SAMPLE COMPARED TO REPEAT TESTING FROM DIFFERENT LOT NUMBER. THE REPEAT TESTING WAS PERFORMED WITH LOT 319 AS THE CUSTOMER DID NOT HAVE REAGENT LOT 317 AVAILABLE. THE CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED FOR SYSTEM INSPECTION AND NO ISSUES WERE IDENTIFIED. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "NOTE MULTIPLE FORMS OF IMMUNOREACTIVE CALCITONIN ARE PRESENT IN THE CIRCULATION OF HEALTHY SUBJECTS, PATIENTS WITH MEDULLARY THYROID CARCINOMA, AND PATIENTS WITH OTHER MALIGNANCIES. THESE DIFFERENT FORMS OF CALCITONIN (POLYMERS AND/OR GLYCOSYLATED FORMS) CAN HAVE MOLECULAR WEIGHTS VARYING FROM 3.4 TO 70 KDA. THEREFORE, SAMPLES MAY EXHIBIT VARIED RESPONSE IN AN IMMUNOASSAY AND NON-LINEAR DILUTION. 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." SIEMENS IS INVESTIGATING.

Description of Event or Problem

CUSTOMER OBSERVED A DEPRESSED IMMULITE 2000 CALCITONIN RESULT FROM A SAMPLE THAT WAS CONSIDERED DISCORDANT WITH THE REPEAT RESULT TESTED WITH A DIFFERENT REAGENT LOT NUMBER. THE DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CALCITONIN RESULT.

Additional Manufacturer Narrative

A US CUSTOMER OBSERVED DEPRESSED IMMULITE 2000 CALCITONIN RESULT FOR A PATIENT SAMPLE COMPARED TO REPEAT TESTING FROM DIFFERENT LOT NUMBER. THE REPEAT TESTING WAS PERFORMED WITH LOT 319 AS THE CUSTOMER DID NOT HAVE REAGENT LOT 317 AVAILABLE. THE CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED FOR SYSTEM INSPECTION AND NO ISSUES WERE IDENTIFIED. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "NOTE MULTIPLE FORMS OF IMMUNOREACTIVE CALCITONIN ARE PRESENT IN THE CIRCULATION OF HEALTHY SUBJECTS, PATIENTS WITH MEDULLARY THYROID CARCINOMA, AND PATIENTS WITH OTHER MALIGNANCIES. THESE DIFFERENT FORMS OF CALCITONIN (POLYMERS AND/OR GLYCOSYLATED FORMS) CAN HAVE MOLECULAR WEIGHTS VARYING FROM 3.4 TO 70 KDA. THEREFORE, SAMPLES MAY EXHIBIT VARIED RESPONSE IN AN IMMUNOASSAY AND NON-LINEAR DILUTION. 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." SIEMENS IS INVESTIGATING.