BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 4973512 · Received August 5, 2015

    Report

    Report Number
    1823260-2015-03934
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 16, 2015
    Report Date
    August 5, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE FREE THYROXINE (FT4) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS < 0.02 NG/DL. AS THE RESULT WAS LOW, THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 1.15 NG/DL ON TWO OTHER MODULES. INFORMATION CONCERNING WHICH RESULT WAS REPORTED OUTSIDE THE LAB WAS REQUESTED, BUT WAS NOT PROVIDED. NO ADVERSE EVENT WAS REPORTED. THE REAGENT LOT NUMBER WAS 183473-03. THE EXPIRATION DATE WAS 01/30/2016. THE FIELD SERVICE REPRESENTATIVE CHECKED THE INSTRUMENT AND FOUND A DIRTY AND MISALIGNED SAMPLE PROBE AND A BENT MIXER PADDLE. HE REPLACED AND ADJUSTED THE PROBE, REPLACED AND ADJUSTED THE MIXER PADDLE, AND CHECKED THE ALARM TRACE, BUT FOUND NO RELATED ALARM. THE INVOLVED REAGENT PACK WAS CHECKED, BUT NO ISSUES WERE FOUND. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. BASED ON THE PROVIDED DATA, A GENERAL REAGENT ISSUE WAS NOT SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513572 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1