BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 4330829 · Received December 15, 2014

    Report

    Report Number
    1823260-2014-09985
    Event Type
    Malfunction
    Date Received
    December 15, 2014
    Date of Event
    December 5, 2014
    Report Date
    January 5, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. A GENERAL INSTRUMENT OR REAGENT ISSUE WAS UNLIKELY AS NO ISSUES WERE FOUND BY THE FIELD SERVICE REPRESENTATIVE, THE ALARM TRACE INDICATED NO ISSUES, AND CALIBRATION AND QC WERE ACCEPTABLE.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE TESTOSTERONE RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 12.5 NG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AS THE RESULT FOR THIS PATIENT LAST MONTH WAS 454 NG/DL. THE SAME POUR OFF TUBE WAS REPEATED AND THE RESULT WAS 427 NG/DL ON ANOTHER ANALYZER. THEY REPEATED THE SAMPLE MULTIPLE TIMES AND GOT RESULTS BETWEEN 400 AND 450 NG/DL ON VARIOUS MODULES. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THERE WAS NO ADVERSE EFFECT TO PATIENT. THE REAGENT LOT NUMBER WAS 17878202 WITH AN EXPIRATION DATE OF 10/31/2015. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A PROBLEM. HE EXAMINED THE UNIT AND RAN PERFORMANCE TESTING WITH RESULTS WITHIN SPECIFICATION. HE CHECKED AND INSPECTED THE INSTRUMENT AND CHECKED THE FLUID AND WASH CYCLES. HE REVIEWED THE CALIBRATION AND CONTROLS WHICH WERE OK. HE CHECKED THE SAMPLE INTEGRITY WHICH WAS OK. HE CHECKED THE SAMPLE PROBE AND LLD VOLTAGE AND FOUND THE SAMPLE TIP WAS SLIGHTLY DIRTY. HE CLEANED IT AND RECHECKED THE VOLTAGE WHICH WAS OK. HE REVIEWED THE CLEANING PROCEDURE FOR THE SAMPLE PROBE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819853 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 044 YR