BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-02599

    MDR report key: 7028186 · Received November 14, 2017

    Report

    Report Number
    1823260-2017-02599
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Date of Event
    October 20, 2017
    Report Date
    November 14, 2017
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE HIGH ASTL ASPARTATE AMINOTRANSFERASE RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 248 U/L WITH A DATA FLAG AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED WITH A RESULT OF 44 U/L. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 223106. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S ALP AND ALT WERE ALSO REPEATED AND THE RESULTS MATCHED THE ORIGINAL RESULTS. THE CUSTOMER PERFORMED A PRECISION STUDY FOR AST USING A PATIENT SAMPLE AND HAD NO ISSUES. THE FIELD SERVICE REPRESENTATIVE FOUND PRECIPITANT ON THE RINSE NOZZLE. HE CLEANED THE RINSE NOZZLE, CHECKED THE GEAR PUMP AND SYSTEM FOR CONTAMINATION, AND CHECKED ALL LEVELS. PRECISION TESTING AND QC WAS PERFORMED AND WAS ACCEPTABLE.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR