BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6864290

    MDR report key: 6864290 · Received September 14, 2017

    Report

    Report Number
    6864290
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    August 26, 2017
    Report Date
    September 8, 2017
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT A WAS BEING EVALUATED IN THE EMERGENCY DEPARTMENT (ED), TROPONIN TEST WAS ORDERED AS PART OF THE WORK UP. SAMPLES WERE SUBMITTED TO LAB FOR TESTING: AN ELEVATED CRITICAL (ABNORMAL) RESULT WAS OBTAINED AND REPORTED TO THE HEALTHCARE PROVIDER. SAMPLES FROM PATIENTS B, C, AND D WERE ALSO SUBMITTED FOR TROPONIN TESTING LATER IN THE SAME DAY. ALL RETURNED WITH ABNORMAL VALUES. THE ED NURSING STAFF CALLED THE LAB TO QUESTION TROPONIN VALUES AS THEY DID NOT CORRELATE WITH PATIENT MEDICAL EVALUATION. SAMPLES WERE RETESTED ON ALTERNATE INSTRUMENT AND DIFFERENT RESULTS WERE OBTAINED. THE NURSING TEAM WAS ALERTED TO THESE FINDINGS AND RESULTS CORRECTED IN THE MEDICAL CHART. INSTRUMENT THAT YIELDED ERRONEOUS RESULTS IS A ROCHE E411 MODEL WITH SERIAL NUMBER [REDACTED], WAS PULLED OUT OF SERVICE PENDING INVESTIGATION TO DETERMINE ROOT CAUSE FOR THE ERRONEOUS VALUES.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR NO