BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 4181816 · Received October 17, 2014

    Report

    Report Number
    1415939-2014-00221
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    PMA / PMN Number
    K042731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. THE EVALUATION FOUND THAT THE CALIBRATOR AND CONTROLS USED BY THE CUSTOMER WHEN THE EVENT OCCURRED WERE GREATER THAN SIX MONTHS PAST THEIR EXPIRATION DATE. THIS MAY HAVE IMPACTED THE RESULTS GENERATED. ALSO, THE ORIGINAL SAMPLE USED BY THE CUSTOMER TO GENERATE THE SUSPECT RESULT WAS NOT CENTRIFUGED. A SUBSEQUENT SAMPLE OBTAINED AND PROCESSED APPROPRIATELY GENERATED THE EXPECTED (ACCEPTED) RESULT. THIS SUGGESTS THAT THE CUSTOMER'S ISSUE WAS DUE TO IMPROPER SAMPLE HANDLING AND/OR EVIDENCE OF COMPROMISED SAMPLE INTEGRITY. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT CA 125 ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. THE CURRENT EVALUATION INDICATES THAT THE ARCHITECT CA 125 REAGENT KIT IS PERFORMING AS INTENDED AND NO NEW ISSUES WERE FOUND. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED. CONCOMITANT MEDICAL PRODUCTS: ARCHITECT CA 125 CALIBRATORS, LN: 02K45-01, LOT: 42K38113, EXPIRATION DATE: 03/18/2014, DEVICE MANUFACTURE DATE: 04/01/2013. ARCHITECT CA 124 CONTROLS, LN: 02K45-10, LOT: 42K38213, EXPIRATION DATE: 03/18/2014, DEVICE MANUFACTURE DATE: 04/01/2013. ARCHITECT CA 125, LIST NUMBER TO 02K45-28 (SIZE CODE ONLY).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT ONE PATIENT SAMPLE GENERATED AN ARCHITECT CA 125 II ASSAY RESULT OF 213.80 U/ML. THE SAMPLE WAS SENT FROM ANOTHER LAB WITH VERY MINIMAL VOLUME FOR PROPER PREANALYTICAL PREPARATION. THE CUSTOMER THEN REQUESTED A SECOND SAMPLE. THE SECOND SAMPLE ARRIVED AND WAS TESTED TWO DAYS LATER AND GENERATED RESULTS OF 18.6 AND 19.1 U/ML. CONTROLS WERE WITHIN SPECIFICATIONS ON ALL RUNS, BUT HAD EXPIRED IN MARCH 2014. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661637 ARCHITECT CA 125 II OC 125 DEFINED ANTIGEN LTK ABBOTT LABORATORIES 36298M500

    Patients

    Seq Age Sex Outcome Treatment
    1 SN: (B)(4)| ARCHITECT I1000SR ANALYZER LN: 01L86-01| ARCHITECT I1000SR ANALYZER LN: 01L86-01| SN: (B)(4)