BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 CALCITONIN

    MDR report key: 6948230 · Received October 13, 2017

    Report

    Report Number
    2247117-2017-00114
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    September 5, 2017
    Report Date
    November 30, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    JKR
    UDI-DI
    00630414945422
    PMA / PMN Number
    K023304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION (06-NOVEMBER-2017): THE PATIENT WAS ALSO EVALUATED FOR INSULIN-LIKE GROWTH FACTOR ON SEPTEMBER 3, 2017 AND SEPTEMBER 8, 2017 RESULTING AS 302.0 NG/ML AND 315.0 NG/ML RESPECTIVELY. ADDITIONAL INFORMATION (27-NOVEMBER-2017): A NEW SAMPLE DRAW WAS OBTAINED FROM THE PATIENT AND WAS TESTED WITH THE IMMULITE 2000 CALCITONIN ASSAY IN REPLICATES OF FIVE AND THE RESULTS WERE REPRODUCIBLE. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE EVENT DATA. THE CUSTOMER HAD VARIABLE RESULTS WHEN TESTING THE ORIGINAL SAMPLE DRAW FROM THE PATIENT WITH THE IMMULITE 2000 CALCITONIN ASSAY ON TWO DIFFERENT INSTRUMENTS. CENTRIFUGING THE SAMPLE DID NOT ELIMINATE THE VARIABILITY. WHEN THE CUSTOMER TESTED ANOTHER SAMPLE DRAW FROM THE PATIENT WITH THE IMMULITE 2000 CALCITONIN ASSAY THE RESULTS WERE REPRODUCIBLE. SO THE REPRODUCIBILITY ISSUE WITH THE ORIGINAL SAMPLE WAS SPECIFIC TO THAT SAMPLE DRAW AND NOT SPECIFIC TO THE PATIENT. THE TUBE TYPE IS UNKNOWN, THEREFORE, IT COULD NOT BE ASSESSED WHETHER AN INGREDIENT IN THE TUBE WAS CAUSING AN ISSUE. THE CUSTOMER RUNS 3,500 IMMULITE 2000 CALCITONIN TESTS PER MONTH AND THIS WAS THE ONLY SAMPLE WITH THE ISSUE. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED, HOWEVER, THERE APPEARS TO BE SOMETHING IN THE SAMPLE THAT IS INTERFERING WITH THE ASSAY. BASED ON THE AVAILABLE INFORMATION THE IMMULITE 2000 CALCITONIN ASSAY IS PERFORMING AS INTENDED. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE EVENT DATA. THE HSC SPECIALIST STATED THAT THE IMPRECISE RESULTS WOULD INDICATE A MATRIX ISSUE OR PARTICULATE MATTER IN THE SAMPLE. THE CUSTOMER'S PROCESS FOR CENTRIFUGATION MAY BE INSUFFICIENT TO PREVENT PARTICULATE MATTER FROM INTERFERING WITH THE IMMULITE 2000 CALCITONIN ASSAY. THE HSC SPECIALIST RECOMMENDS THAT THE CUSTOMER CENTRIFUGES THE SAMPLE FOR 15 - 20 MINUTES AT 1,000 X GRAVITATIONAL FORCE (G) TO REDUCE THE CHANCE OF PARTICULATE MATTER INTERFERING WITH THE ASSAY. AT 300 REVOLUTIONS PER MINUTE (RPM) THE RADIUS OF THE CUSTOMER'S CENTRIFUGE WOULD HAVE TO BE 10,000 MILLIMETERS (MM) TO REACH 1,000 X G. A SIEMENS TECHNICAL APPLICATION SPECIALIST (TAS) WAS DISPATCHED TO THE CUSTOMER SITE. ON (B)(6) 2017, THE TAS HAD PERFORMED CENTRIFUGATION FOR SAMPLE IN QUESTION FOR 15 MINUTES AT 1000 X G AND THE RESULTS WERE STILL IMPRECISE. THE CAUSE OF THE IMPRECISE CALCITONIN RESULTS ON ONE PATIENT SAMPLE IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE. MDRS 2247117-2017-00113, 2247117-2017-00115, 2247117-2017-00116, AND 2247117-2017-00117 HAVE BEEN FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    IMPRECISE CALCITONIN RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE UPON INITIAL AND REPEAT TESTING ON AN IMMULITE 2000 XPI INSTRUMENT AND WHEN COMPARED WITH ALTERNATE IMMULTE 2000 XPI INSTRUMENT. IT IS UNKNOWN, WHICH RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE IMPRECISE CALCITONIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728001 IMMULITE 2000 CALCITONIN IMMULITE 2000 CALCITONIN JKR SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 CALCITONIN 265 00630414945422

    Patients

    Seq Age Sex Outcome Treatment
    1