BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1912614 · Received December 2, 2010

    Report

    Report Number
    1823260-2010-07110
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    October 25, 2010
    Report Date
    January 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEW
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION PROVIDED DEMONSTRATES THE PTH CALIBRATION AND QUALITY CONTROL AT THE TIME OF THE EVENT WERE ACCEPTABLE AND THE WEEKLY AND MONTHLY MAINTAINENCE HAD BEEN PERFORMED. NO REAGENT OR INSTRUMENT ISSUES WERE DETECTED. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE CUSTOMER WAS NOT USING CUP ADAPTERS WITH 13 MM SAMPLE TUBES AS RECOMMENDED, THIS IS THE MOST LIKELY CAUSE FOR THE INITIAL LOW PTH RESULT. THE PTH RESULTS WERE GENERATED DURING A CORRELATION STUDY. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT AFFECTED.

    Description of Event or Problem · 1

    THE CUSTOMER EXPERIENCED REPRODUCIBILITY ISSUES WITH PARATHYROID HORMONE-INTACT, PARATHORMONE, PARATHYRIN (PTH). THE ISSUE INVOLVED AN EXTERNAL PROFICIENCY SAMPLE AND ONE PATIENT SAMPLE. THE CUSTOMER PROVIDED DISCREPANT PTH RESULTS FOR THE PATIENT SAMPLE. THE INITIAL RESULT WAS 26.19 PG/ML. THE SAMPLE REPEATED ON THE SAME COBAS 6000 E601 MODULE RECOVERED 90.6 PG/ML AND 96.98 PG/ML. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY UNTIL THE SAMPLE HAD BEEN REPEATED. THE PATIENT WAS NOT AFFECTED. THE PTH REAGENT LOT NUMBER WAS 15670104. THE CUSTOMER DECLINED A FIELD SERVICE DISPATCH. SHE HAD PERFORMED A PTH PRECISION STUDY ON (B)(6) 2010 WHICH WAS ACCEPTABLE AND HAD NOT EXPERIENCED ANY OTHER ISSUES WITH RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1