BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 4377975 · Received January 2, 2015

    Report

    Report Number
    2247117-2015-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2015
    Date of Event
    December 8, 2014
    Report Date
    December 9, 2014
    Manufacturer
    SIEMENS HEALTCHCARE DIAGNOSTICS INC
    Product Code
    JLX
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER STATED TO CCC THAT THE SAMPLE APPEARED SLIGHTLY HEMOLYZED AND THAT QUALITY CONTROLS WERE WITHIN RANGE AT THE TIME OF EVENT. IT WAS DISCOVERED THAT THE CUSTOMER WAS CENTRIFUGING PATIENT SAMPLES OUTSIDE OF THE TUBE MANUFACTURER SPECIFICATIONS. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE REPLACED THE REAGENT DUAL RESOLUTION DILUTER DUE TO A CRACKED LOWER PISTON AND THE DILUTION WELL DUE TO A NOISY BEARING. THE CSE DECONTAMINATED THE FLUIDIC AND SUBSTRATE SYSTEMS. QUALITY CONTROLS AND A WATER TEST WERE RUN, ALL OF WHICH PASSED. THE CAUSE OF THE DISCORDANT, FALSELY LOW PROGESTERONE RESULT IS UNKNOWN. THE CAUSE OF THE SAMPLES BEING CENTRIFUGED OUTSIDE OF TUBE VENDOR SPECIFICATIONS IS FAILURE TO FOLLOW INSTRUCTIONS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW PROGESTERONE RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR VALIDATION ON THE SAME INSTRUMENT, RESULTING HIGHER. THE SAMPLE WAS THEN REPEATED AGAIN ON THE SAME INSTRUMENT, RESULTING SIMILARLY TO THE PREVIOUS REPEAT RESULT. IT IS UNKNOWN IF THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW PROGESTERONE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925 IMMULITE 2000 IMMULITE 2000 JLX SIEMENS HEALTCHCARE DIAGNOSTICS INC IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1