BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03952

    MDR report key: 4996689 · Received August 12, 2015

    Report

    Report Number
    1823260-2015-03952
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 21, 2015
    Report Date
    September 2, 2015
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. IT WAS NOTED THE CUSTOMER WAS NOT FOLLOWING THE TUBE MANUFACTURER'S RECOMMENDATION FOR CENTRIFUGATION TIME. THIS MAY HAVE LED TO PRE-ANALYTIC ISSUE WITHIN CAUSED OR CONTRIBUTED TO THE ISSUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE TROPONIN T HS STAT RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 8.37 PG/ML. THE PATHOLOGIST QUERIED THE RESULT AS THIS DID NOT AGREE WITH PREVIOUS RESULTS AND CLINICAL PICTURE. THE SAMPLE WAS REPEATED AND THE RESULT WAS 102.2 PG/ML WITH A DATA FLAG. THE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 182603. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED. IT WAS NOTED THE CUSTOMER WAS NOT USING THE RECOMMENDED SAMPLE TUBE RACK ADAPTERS. THIS MAY HAVE ALLOWED THE SAMPLE TUBE TO LEAN AND CAUSE ASPIRATION ISSUES WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE ISSUE.

    Patients

    Seq Age Sex Outcome Treatment
    1 084 YR