BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2016-00708

    MDR report key: 5694302 · Received June 2, 2016

    Report

    Report Number
    1823260-2016-00708
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Date of Event
    May 16, 2016
    Report Date
    June 22, 2016
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. BASED ON THE DATA, A HARDWARE ISSUE AFFECTING THE LIQUID LEVEL DETECTION OF THE ANALYZER MAY HAVE BEEN RESPONSIBLE FOR THE EVENT SINCE IT WAS OBSERVED IN THE ALARM TRACE THAT THERE WAS A SAMPLE LIQUID LEVEL MALFUNCTION DURING MOVEMENT. THE PRECISION CHECKS PERFORMED AFTER THE FIELD SERVICE VISIT WERE IN RANGE. THE FIELD SERVICE REPRESENTATIVE DID NOT IDENTIFY ANY ISSUES ON THE INSTRUMENT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS LOW RESULT FOR ONE PATIENT SAMPLE TESTED FOR INTACT HUMAN CHORIONIC GONADOTROPIN + THE BETA-SUBUNIT (HCGB) ON AN E411 ANALYZER. THE SAMPLE INITIALLY RESULTED AS 0.685 IU/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR. THE SAMPLE WAS REPEATED ON (B)(6) 2016, RESULTING AS 4022 IU/L ACCOMPANIED BY A DATA FLAG. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE HCGB REAGENT LOT NUMBER WAS 190280. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE CHECKED THE ANALYZER AND RAN PERFORMANCE TESTING. HE NOTED THAT THERE WERE NO OBVIOUS FIBRIN STRANDS IN THE SAMPLE.

    Patients

    Seq Age Sex Outcome Treatment
    1