BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-00582

    MDR report key: 6417460 · Received March 20, 2017

    Report

    Report Number
    1823260-2017-00582
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    January 18, 2017
    Report Date
    March 20, 2017
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE HIGH GLUC3 GLUCOSE HK RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES. ONE EXAMPLE WAS PROVIDED AS AN INITIAL RESULT OF 150 MG/DL AND A REPEAT RESULT OF 107 MG/DL. ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 193436. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. REVIEW OF THE PROVIDED CALIBRATION DATA DID NOT INDICATE A REAGENT ISSUE BUT DUE TO MULTIPLE ERRORS FOUND, AN ISSUE WITH THE CALIBRATOR HANDLING OR THE ANALYZER PERFORMANCE WAS SUSPECTED. IMPRECISION AND SPORADIC OUTLIERS IN THE QC DATA INDICATED AN ISSUE WITH THE GEAR PUMP, THE WASH EFFICIENCY, OR THE SAMPLE/REAGENT PROBE PIPETTING WAS POSSIBLE.

    Patients

    Seq Age Sex Outcome Treatment
    1