BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-00374

    MDR report key: 6342821 · Received February 20, 2017

    Report

    Report Number
    1823260-2017-00374
    Event Type
    Malfunction
    Date Received
    February 20, 2017
    Date of Event
    January 26, 2017
    Report Date
    March 21, 2017
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. POSSIBLE GENERAL ROOT CAUSES INCLUDE INSUFFICIENT ELECTROMAGNETIC INTERFERENCE (EMI) LABORATORY COMPLIANCE, ISSUES WITH SAMPLE QUALITY, INSUFFICIENT MAINTENANCE, AND CONTAMINATION OF THE ENVIRONMENT WITH THE ANALYTE. MEDWATCH FIELD D4 WAS UPDATED.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE RESULT FOR ELECSYS PTH IMMUNOASSAY. THE INITIAL RESULT WAS 24 PG/ML AND WAS REPORTED TO A PHYSICIAN. THE CUSTOMER RETESTED THE SAMPLE AND THE RESULTS WERE 7.5 PG/ML, 7.38 PG/ML, AND 7.36 PG/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 143251. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE CUSTOMER'S QUALITY CONTROLS WERE CHECKED AND NO PROBLEM WAS IDENTIFIED.

    Patients

    Seq Age Sex Outcome Treatment
    1