BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 7299128 · Received February 27, 2018

    Report

    Report Number
    2247117-2018-00013
    Event Type
    Malfunction
    Date Received
    February 27, 2018
    Date of Event
    February 5, 2018
    Report Date
    April 12, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LGD
    UDI-DI
    00630414945422
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR ON 27-FEB-2018. ADDITIONAL INFORMATION (16-MARCH-2018): HEADQUARTER SUPPORT CENTER (HSC) SPECIALISTS REVIEWED CUSTOMER'S ACTH KIT LOT 305 ADJUSTMENTS AND QUALITY CONTROL (QC) DATA AND THOSE WERE WITHIN RANGES AND COMPARABLE WITH RELEASE DATA. AN INVESTIGATION OF THE DATA LOGS WAS PERFORMED AND CONCLUDED THAT NO SIGNIFICANT SYSTEM ERRORS WERE DETECTED DURING THE TIME THE SAMPLE WAS PROCESSING. THE HSC SPECIALISTS HAVE DETERMINED THE POSSIBLE CAUSE OF THE DISCORDANT IS DUE TO BUBBLES OR FOAM ON THE SAMPLE TUBE AS DATA LOGS INDICATE AN INCONSISTENCY IN THE SAMPLE LEVEL SENSE OF THE INITIAL RESULT. THE INSTRUMENT IS PERFORMING WITHIN MANUFACTURING SPECIFICATIONS. NO FURTHER EVALUATION OF DEVICE IS REQUIRED. METHOD CODE(S): 3372 - ANALYSIS OF DATA (LOGS); RESULT CODE(S): 213 -NO FAILURE DETECTED; CONCLUSION CODE(S): 19-HUMAN FACTORS ISSUE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). SIEMENS IS INVESTIGATING THIS ISSUE.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY DEPRESSED ADRENOCORTICOTROPIC HORMONE (ACTH) RESULT WAS OBTAINTED ON THE IMMULITE 2000 XPI SYSTEM. THE INITIAL RESULT (<5 PG/ML) WAS REPORTED OUT TO THE PHYSICIAN(S) AND THE RESULT WAS QUESTIONED. REPEAT TESTING WAS PERFORMED IN DUPLICATE ON THE SAME SYSTEM AND PATIENT SAMPLE. THE CUSTOMER STATED THAT REPEAT RESULTS WERE HIGHER, CLINICALLY FITTED, AND THAT INTERNAL QUALITY CONTROL (ICQ) AND EXTERNAL QUALITY ASSURANCE (EQA) WERE ACCEPTABLE. A CORRECTED REPORT WAS ISSUED.THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED ACTH PATIENT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142137 IMMULITE 2000 XPI IMMULITE 2000 XPI LGD SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 XPI 00630414945422

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR