BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ELECSYS HSV-1 IGG IMMUNOASSAY

    MDR report key: 8549742 · Received April 25, 2019

    Report

    Report Number
    1823260-2019-90090
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    March 20, 2019
    Report Date
    April 25, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MXJ
    PMA / PMN Number
    K120625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS REQUESTED FOR INVESTIGATION BUT COULD NOT BE PROVIDED. CALIBRATION AND QC WERE ACCEPTABLE. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NON-REACTIVE TEST RESULTS DO NOT COMPLETELY RULE OUT THE POSSIBILITY OF HSV-1 INFECTION. INDIVIDUALS MAY NOT EXHIBIT ANY DETECTABLE IGG ANTIBODIES AT AN EARLY STAGE OF ACUTE INFECTION. FALSE NEGATIVE RESULTS MAY OCCUR WHEN THE HS-VIRUS IS GLYCOPROTEIN G (GG) DEFICIENT.

    Description of Event or Problem · 0

    THE INITIAL REPORT WAS INADVERTENTLY FILED AS A VOLUNTARY MANUFACTURER SUMMARY REPORT. THIS SUPPLEMENTAL IS TO UPDATE MISSING INFORMATION. THE INITIAL REPORTER COMPLAINED OF A FALSE NEGATIVE RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS HSV-1 IGG IMMUNOASSAY (HSV-1 IGG) ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL RESULT FROM THE E411 ANALYZER WAS 0.072 COI (NEGATIVE). THE REPEAT FROM THE E411 ANALYZER WAS 0.070 COI (NEGATIVE). ON (B)(6) 2019 THE REPEAT FROM THE E411 ANALYZER WAS 0.085 (NEGATIVE). THE SAMPLE WAS TESTED BY THE LIAISON DIASORIN METHOD WITH A "NEGATIVE" RESULT. THE ACTUAL RESULT WAS NOT PROVIDED. THE SAMPLE WAS TESTED BY THE IMMULITE AND ECOLAB METHODS AND THE RESULTS WERE "POSITIVE." THE ACTUAL RESULTS WERE NOT PROVIDED. THE PATIENT CLAIMED TO BE HSV POSITIVE AND HAD BEEN RECEIVING TREATMENT IN ANOTHER MEDICAL FACILITY FOR "SOME TIME." FURTHER DETAILS ABOUT THE MEDICATION AND SPECIFIC TIME FRAMES WERE NOT AVAILABLE. THE E411 ANALYZER SERIAL NUMBER WAS (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATIONS FOR THE 1 EVENT DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NON-REACTIVE TEST RESULTS DO NOT COMPLETELY RULE OUT THE POSSIBILITY OF HSV-1 INFECTION. INDIVIDUALS MAY NOT EXHIBIT ANY DETECTABLE IGG ANTIBODIES AT AN EARLY STAGE OF ACUTE INFECTION. FALSE NEGATIVE RESULTS MAY OCCUR WHEN THE HS-VIRUS IS GLYCOPROTEIN G (GG) DEFICIENT. THE FOLLOW UP/CORRECTIVE ACTIONS FOR THE 1 EVENT WAS AS FOLLOWS: THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION BUT COULD NOT BE PROVIDED. NO DEVICES WERE RETURNED. THIS DEVICE IS NOT LABELED FOR SINGLE USE AND IS NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. AN ERRONEOUS LOW RESULT WAS GENERATED BY THE COBAS E 411 IMMUNOASSAY ANALYZER. THE EVENTS INVOLVED A TOTAL OF 1 PATIENT WITH THE FOLLOWING: A LOW ELECSYS HSV-1 IGG IMMUNOASSAY (HSV-1 IGG) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343995 ELECSYS HSV-1 IGG IMMUNOASSAY HERPES SIMPLEX VIRUS, HSV-1 MXJ ROCHE DIAGNOSTICS HSV-1 30828200

    Patients

    Seq Age Sex Outcome Treatment
    1