BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3890116 · Received June 24, 2014

    Report

    Report Number
    1823260-2014-04618
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 HUMAN CHORIONIC GONADOTROPIN (HCG) STAT RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 480.3 MIU/ML AND WAS REPORTED OUTSIDE THE LABORATORY. THE ER DOCTOR CALLED TO QUESTION THE RESULT AND AN ALIQUOT OF THE SAME SAMPLE WAS REPEATED WITH A RESULT OF >10000 MIU/ML WITH DATA FLAG. UPON AUTO DILUTION, THE RESULT WAS 34125 MIU/ML. AN ALIQUOT OF THE SAMPLE WAS TESTED ON A COBAS E411 ANALYZER WITH A DILUTION AND THE RESULT WAS 43237 MIU/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE CUSTOMER DID NOT THINK THE PATIENT WAS AFFECTED. THE HCG REAGENT LOT NUMBER WAS 17551301 WITH AN EXPIRATION DATE OF 04/30/2015. THE FIELD SERVICE REPRESENTATIVE FOUND THE SAMPLE PROBE WAS MISADJUSTED WHICH WAS CAUSING THE SAMPLE PROBE TO MISALIGN WITH THE TUBE FOR SAMPLE PIPETTING. HE PERFORMED AN ADJUSTMENT TO READJUST THE SAMPLE PROBE POSITIONS. HE RAN A MECHANISM CHECK AND RAN THE SUBJECT SAMPLE IN A TUBE WITH A RESULT WITHIN THE EXPECTED LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369201 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 019 YR