BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 CALCITONIN

    MDR report key: 6169973 · Received December 13, 2016

    Report

    Report Number
    2432235-2016-00755
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 4, 2016
    Report Date
    December 13, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    JKR
    PMA / PMN Number
    K023304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL APPLICATION SPECIALIST (TAS) WAS DISPATCHED TO THE CUSTOMER SITE. THE TAS RAN THE PATIENT SAMPLE IN QUESTION USING A HETEROPHILIC BLOCKING TUBE AND THE RESULT WAS ACCEPTABLE. AS PER IMMULITE 2000 CALCITONIN INSTRUCTIONS FOR USE, "HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH THE IMMUNOGLOBULINS INCLUDED IN THE ASSAY COMPONENTS CAUSING INTERFERENCE WITH IN VITRO IMMUNOASSAYS. SAMPLES FROM PATIENTS ROUTINELY EXPOSED TO ANIMALS OR ANIMAL SERUM PRODUCTS CAN DEMONSTRATE THIS TYPE OF INTERFERENCE POTENTIALLY CAUSING AN ANOMALOUS RESULT. THESE REAGENTS HAVE BEEN FORMULATED TO MINIMIZE THE RISK OF INTERFERENCE; HOWEVER, POTENTIAL INTERACTIONS BETWEEN RARE SERA AND TEST COMPONENTS CAN OCCUR. 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." A SIEMENS HEADQUARTERS SUPPORT CENTER SPECIALIST REVIEWED THE DATA PROVIDED BY THE CUSTOMER AND INDICATED THAT IMMULITE 2000 CALCITONIN ASSAY IS PERFORMING AS INTENDED. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED CALCITONIN RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT UPON INITIAL AND REPEAT TESTING, WHILE USING KIT LOT 259. THE SAMPLE WAS REPEATED ON AN ALTERNATE IMMULITE INSTRUMENT, ALSO RESULTING ELEVATED. THE SAMPLE WAS TESTED ON AN ALTERNATE PLATFORM AND THE RESULT WAS LOWER. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. IT IS UNKNOWN IF THE CORRECTED RESULT OBTAINED ON THE ALTERNATE PLATFORM WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CALCITONIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820899 IMMULITE 2000 CALCITONIN IMMULITE 2000 CALCITONIN JKR SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 CALCITONIN 259

    Patients

    Seq Age Sex Outcome Treatment
    1