BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1904953 · Received November 22, 2010

    Report

    Report Number
    1823260-2010-06861
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 1, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE. IT WAS NOTED THE CUSTOMER MAY HAVE INTRODUCED AIR BUBBLES INTO THE SAMPLE WHILE POURING THE SAMPLE INTO THREE ALIQUOTS. POURING OF SAMPLES IS NOT RECOMMENDED. THIS IS MOST LIKELY THE CAUSE OF THE EVENT. THE PATIENT WAS NOT ADVERSELY AFFECTED.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + SS-SUBUNIT (HCG+SS) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.100 MIU/ML WITH A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR CALLED THE LABORATORY AND REQUESTED A VALIDITY CHECK ON THE SAMPLE. ON (B)(6) 2010, THE SAMPLE WAS REPEATED ON A MODULE NAMED "E9-1" AND THE RESULTS WERE 79826 (1:100 DILUTION), 10000, 84208 (1:100 DILUTION) AND 10000 MIU/ML. ALL THE REPEAT RESULTS WERE ACCOMPANIED BY DATA FLAGS. THE SAMPLE WAS ALSO REPEATED ON A MODULE NAMED "E9-2" AND THE RESULTS WERE 10000, 88957 (1:100 DILUTION), 10000 AND 78910 (1:100 DILUTION) MIU/ML. ALL THE REPEAT RESULTS WERE ACCOMPANIED BY DATA FLAGS. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE HCG+SS REAGENT LOT NUMBER WAS 15851502. THE FIELD SERVICE REPRESENTATIVE FOUND THE SAMPLE CONTAINED FIBRIN PARTICLES. HE RAN INSTRUMENTS CHECKS, CALIBRATION, QUALITY CONTROL AND SAMPLES TO VERIFY THE ANALYZER OPERATION. HE OBSERVED ALL CHECKS AND SAMPLES FOR PARTICLES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 020 YR