BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 HERPES I & II

    MDR report key: 1408898 · Received March 9, 2009

    Report

    Report Number
    2017183-2009-00010
    Event Type
    Other
    Date Received
    March 9, 2009
    Date of Event
    February 5, 2009
    Report Date
    February 11, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    GQL
    PMA / PMN Number
    K010878
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF INSTRUMENT AND INSTRUMENT DATA DIDN'T INDICATE SYSTEM ERROR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IT HAS BEEN COMMUNICATED TO THE CUSTOMER THAT USE OF CSF FOR THIS ASSAY IS OUTSIDE OF THE PRODUCT INTENDED USE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCORDANT IMMULITE 2000 (B)(6) QUALITATIVE ASSAY RESULT OBTAINED ON A PATIENT SAMPLE USING CEREBRAL SPINAL FLUID (CSF) AS SAMPLE TYPE. INITIAL AND REPEATED RESULTS WERE INDICATED AS NONREACTIVE. THE CUSTOMER ESTABLISHED ITS OWN METHOD FOR CSF SAMPLE TYPE WITH NONREACTIVE VALUE RESULT TO BE MULTIPLIED BY 4.3 AND REVIEW AGAINST THE REFERENCE RANGE. CSF SAMPLE TYPE IS NOT RECOMMENDED TO USE ON THIS ASSAY AND CUSTOMER PRACTICE OF RE-INTERPRETING THE RESULT IS NOT SUPPORTED BY MANUFACTURER IFU. IT'S UNK WHETHER PATIENT TREATMENT WERE ALTERED AND NO INDICATION OF PATIENT TREATMENT ADMINISTERED. PATIENT TREATMENT IS UNK AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO CUSTOMER OFF-LABEL USAGE OF THE (B)(6) ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 HERPES I & II HERPES I & II IGG IMMUNOASSAY GQL SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA 216

    Patients

    Seq Age Sex Outcome Treatment
    1 Other