BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01832

    MDR report key: 6824048 · Received August 28, 2017

    Report

    Report Number
    1823260-2017-01832
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    August 1, 2017
    Report Date
    September 27, 2017
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE CALIBRATION AND QC DATA PROVIDED, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE MOST PROBABLE ROOT CAUSE APPEARED TO BE ISSUES WITH THE PRE-ANALYTIC HANDLING OF THE SAMPLES AS MULTIPLE ASPIRATION ALARMS, INDICATING EITHER CLOT OR INADEQUATE SAMPLE VOLUME WERE PRESENT IN THE PROVIDED ANALYZER ALARM TRACE. OTHER TYPICAL ROOT CAUSES FOR THIS TYPE OF EVENT INCLUDE INSUFFICIENT ELECTROMAGNETIC INTERFERENCE (EMI) COMPLIANCE, ISSUES WITH SAMPLE QUALITY, INSUFFICIENT MAINTENANCE, OR CONTAMINATION OF THE ENVIRONMENT WITH THE ANALYTE. THE CUSTOMER WAS NOT USING THE MANDATORY SAMPLE TUBE RACK ADAPTERS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE HIGH ELECSYS TSH ASSAY RESULTS FOR SIX PATIENT SAMPLES. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT AND WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 220841. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1