BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3222728 · Received July 12, 2013

    Report

    Report Number
    1823260-2013-04224
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 29, 2013
    Report Date
    July 22, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED DOCUMENTING THE HUMIDITY VALUE IN THE LABORATORY AT THE TIME OF THE EVENT WAS 42% IS BELOW THE SPECIFICATIONS PROVIDED IN PRODUCT LABELING. THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. BASED ON THE PROVIDED CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE WAS NOT LIKELY.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCG+SS) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.106 MIU/ML AND WAS REPORTED OUT AS <1 MIU/ML. THE ER CALLED QUESTIONING THE RESULT AS THE PATIENT WAS KNOWN TO BE PREGNANT. THEY THEN RERAN THE SAMPLE AND THE RESULT WITH A DILUTION WAS 36168 MIU/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT TREATED BASED ON THE ERRONEOUS RESULT AS THE ER KNEW SHE WAS PREGNANT. THE HCG+SS REAGENT LOT NUMBER WAS 17160105 WITH AN EXPIRATION DATE OF 06/30/2014. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE AND RAN A PRECISION CHECK WITH CONTROL MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323814 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1