BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 RUBELLA IGG

    MDR report key: 1278487 · Received November 24, 2008

    Report

    Report Number
    2017183-2008-00052
    Event Type
    Other
    Date Received
    November 24, 2008
    Date of Event
    May 14, 2008
    Report Date
    September 17, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DGC
    PMA / PMN Number
    K970227
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT RUBELLA IGG RESULT IS UNKNOWN. IT'S SUSPECTED THAT CUSTOMER DID NOT USE THE RECOMMENDED TUBE ON THE INITIAL SAMPLE RESULT. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A LOW POSITIVE IMMULITE 2000 RUBELLA IGG ASSAY RESULT WAS OBTAINED ON A PREGNANT PATIENT SAMPLE. MULTIPLE RETESTING OF THE PATIENT SAMPLE RESULTED IN HIGHER RESULT VALUES. THE LOW RUBELLA IGG RESULT WAS REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW RUBELLA IGG ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 RUBELLA IGG RUBELLA IGG IMMUNOASSAY DGC SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 250

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR