BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HE4

    MDR report key: 4866822 · Received June 24, 2015

    Report

    Report Number
    3002809144-2015-00043
    Event Type
    Malfunction
    Date Received
    June 24, 2015
    Date of Event
    May 7, 2015
    Report Date
    August 20, 2015
    Manufacturer
    ABBOTT GERMANY
    Product Code
    OIU
    PMA / PMN Number
    K093957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP EMDR IS BEING SUBMITTED TO CORRECT THE PRODUCT CODE. SUSPECT MEDICAL DEVICE. THE CORRECT PRODUCT CODE FOR THIS MEDICAL DEVICE, ARCHITECT (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    REVIEW OF TICKET TRENDING AND LOT SEARCH DATA DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO DISCREPANT PATIENT RESULTS. ACCURACY TESTING WAS COMPLETED USING RETAINED KITS OF REAGENT LOT 42042M500. ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. A DEFICIENCY WAS NOT IDENTIFIED AS ACCURACY TESTING SHOWS THAT THE ASSAY PERFORMS PER SPECIFICATION. NO MALFUNCTION WAS IDENTIFIED SINCE THE ISSUE INVOLVES ONE DISCREET PATIENT AND THE SENSITIVITY FOR STRATIFYING PATIENTS WITH STAGE I-IV EPITHELIAL OVARIAN CANCER INTO THE HIGH RISK GROUP IS 93% AT A SPECIFICITY OF 75%. ADDITIONALLY, THE LIMITATIONS OF THE PROCEDURE AND EXPECTED VALUES SECTION OF THE ARCHITECT HE4 PACKAGE INSERT ADDRESSES THE CUSTOMER'S ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A FALSELY DECREASED ARCHITECT HE4 RESULT OF 33.2 PMOL/L WAS GENERATED FOR A PATIENT WITH A CA 125 RESULT OF 433.1 U/ML AND 3.6% ROMA (RISK OF OVARIAN MALIGNANCY ALGORITHM) ON (B)(6) 2015. THIS TESTING WAS PERFORMED BECAUSE A PELVIC MASS WAS FOUND IN THE PATIENT'S SONOGRAPHY REPORT. SURGERY WAS PERFORMED ON (B)(6) 2015 AND THE HISTOPATHOLOGICAL DIAGNOSIS REVEALED SERIOUS CARCINOMA OF THE OVARY. THE POST-SURGICAL ROMA WAS 49.8%. A POST-SURGICAL HE4 RESULT WAS NOT PROVIDED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409783 ARCHITECT HE4 HE4 OIU ABBOTT GERMANY 42042M500

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR LIST 01L86-01, SERIAL (B)(4)| ARCHITECT I1000SR ANALYZER| LIST 01L86-01, SERIAL (B)(4)