BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 CALCITONIN

    MDR report key: 6092750 · Received November 10, 2016

    Report

    Report Number
    2432235-2016-00686
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 18, 2016
    Report Date
    December 27, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    JKR
    PMA / PMN Number
    K023304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2016-00686 WAS FILED ON NOVEMBER 10, 2016. ADDITIONAL INFORMATION (12/08/2016): A SIEMENS HEADQUARTERS SUPPORT CENTER SPECIALIST REVIEWED THE DATA PROVIDED BY THE CUSTOMER AND STATED THAT THE CUSTOMER SAW HIGHER RECOVERY WHEN MANUALLY DILUTING A SAMPLE. HOWEVER, THE CUSTOMER DID NOT ADD THE REQUIRED DEIONIZED (DI) WATER TO THE DILUENT BEFORE PERFORMING THE MANUAL DILUTION. THE CUSTOMER HAS AMENDED THEIR STANDARD OPERATING PROCEDURE, SO THAT IF THERE IS EVER A NEED TO PERFORM A MANUAL DILUTION IN THE FUTURE THEY WILL INCLUDE DI WATER AT THE CORRECT RATIO. IMMULITE 2000 CALCITONIN KIT LOT 258 IS PERFORMING AS INTENDED. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) SPECIALIST. THE CUSTOMER PERFORMED MANUAL DILUTION FOR CALCITONIN. THE CUSTOMER DID NOT ADD DE-IONIZER TO THE DILUENT PRIOR TO THE DILUTION. THE CAUSE OF THE DISCORDANT CALCITONIN RESULTS ON ONE PATIENT SAMPLE IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    DISCORDANT CALCITONIN RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE WHEN RUN NEAT VS. DILUTED ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING REAGENT LOT 258. IT IS UNKNOWN WHICH RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CALCITONIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744644 IMMULITE 2000 CALCITONIN IMMULITE 2000 CALCITONIN JKR SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 CALCITONIN 258

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR