BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 5074031 · Received September 14, 2015

    Report

    Report Number
    1823260-2015-04142
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    July 29, 2015
    Report Date
    December 15, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. FURTHER CLARIFICATION WAS NOT POSSIBLE WITH AVAILABLE INFORMATION. SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND WAS TESTED ON AN ABBOTT ANALYZER AND A SIEMENS IMMULITE ANALYZER. THE RESULTS WERE ABOVE THE REFERENCE RANGES AND CONFIRMED THE PATHOLOGIC HIGH INSULIN RESULT FOR THE PATIENT. BASED ON THE PROVIDED DATA, A GENERAL REAGENT OR INSTRUMENT ISSUE WAS NOT SUSPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE INSULIN RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 481.6 UU/ML. ON (B)(6) 2015, THE ALIQUOT FROM THE SAME SAMPLE WAS SENT TO ANOTHER LAB AND MEASURED ON AN ABBOTT INSTRUMENT. THE RESULT WAS 128.4 UU/ML. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 180953. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606506 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR