BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HE4 ASSAY

    MDR report key: 13284875 · Received January 18, 2022

    Report

    Report Number
    1823260-2022-00140
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    December 24, 2021
    Report Date
    January 18, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    OIU
    UDI-DI
    04015630929641
    PMA / PMN Number
    K112624
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL QC RESULTS WERE OUTSIDE OF THE TARGET RANGE; THE REPEAT QC RESULTS WERE WITHIN THE TARGET RANGE. MICROBEADS WERE FOUND AGGLUTINATED ON THE LID OF THE REAGENT PACK IN QUESTION. THE ISSUE WAS RESOLVED WHEN THE CUSTOMER CHANGED TO A DIFFERENT REAGENT PACK. A GENERAL REAGENT ISSUE CAN BE EXCLUDED AS THE REPEAT RESULTS FROM A DIFFERENT REAGENT PACK WITH THE SAME LOT NUMBER GAVE EXPECTED RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A TRANSPORTATION OR STORAGE ISSUE AFFECTING ONE PARTICULAR REAGENT PACK.

    Additional Manufacturer Narrative · 0

    THE INITIAL QC RESULTS WERE OUTSIDE OF THE TARGET RANGE; THE REPEAT QC RESULTS WERE WITHIN THE TARGET RANGE. MICROBEADS WERE FOUND AGGLUTINATED ON THE LID OF THE REAGENT PACK IN QUESTION. THE ISSUE WAS RESOLVED WHEN THE CUSTOMER CHANGED TO A DIFFERENT REAGENT PACK. A GENERAL REAGENT ISSUE CAN BE EXCLUDED AS THE REPEAT RESULTS FROM A DIFFERENT REAGENT PACK WITH THE SAME LOT NUMBER GAVE EXPECTED RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A TRANSPORTATION OR STORAGE ISSUE AFFECTING ONE PARTICULAR REAGENT PACK.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 8 PATIENT SAMPLES TESTED FOR ELECSYS HE4 ASSAY (HE4) ON A COBAS 8000 E 602 MODULE. THE QUESTIONABLE RESULTS WERE FROM ONE PARTICULAR REAGENT PACK. THE REPEAT RESULTS WERE FROM THE SAME LOT NUMBER BUT A DIFFERENT REAGENT PACK. REFER TO ATTACHED DATA FOR THE RESULTS. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E602 MODULE SERIAL NUMBER WAS (B)(4).

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 8 PATIENT SAMPLES TESTED FOR ELECSYS HE4 ASSAY (HE4) ON A COBAS 8000 E 602 MODULE. THE QUESTIONABLE RESULTS WERE FROM ONE PARTICULAR REAGENT PACK. THE REPEAT RESULTS WERE FROM THE SAME LOT NUMBER BUT A DIFFERENT REAGENT PACK. REFER TO ATTACHED DATA FOR THE RESULTS. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E602 MODULE SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233713 ELECSYS HE4 ASSAY EPITHELIAL OVARIAN TUMOR ASSOCIATED ANTIGEN (HE4) TEST OIU ROCHE DIAGNOSTICS NA 533180 04015630929641

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown