BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1901927 · Received November 18, 2010

    Report

    Report Number
    1823260-2010-06805
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 3, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIF
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    BASED ON THE REACTION KINETICS FOR THE SAMPLE, IT WAS DETERMINED THE SAMPLE EITHER WAS TURBID OR SOMEHOW COLORED, SO THAT A REGULAR MEASUREMENT WAS NOT POSSIBLE. A DATA FLAG WAS GENERATED BY THE ANALYZER, NOTIFYING THE USER THERE MAY BE A PROBLEM WITH THE RESULT. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD REQUIRED REPOSITIONING ONE DAY POST IMPLANT DUE TO DISLODGEMENT. IT WAS REPORTED THAT THE CAUSE OF THE LEAD DISLODGEMENT WAS THAT THE PATIENT ACTIVELY USED HER ARM AFTER IMPLANT AGAINST THE PHYSICIAN'S ORDERS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE NH3L (AMMONIA) RESULTS FOR TWO PATIENT SAMPLES. DATA WAS PROVIDED FOR ONE SAMPLE THAT WAS DISCREPANT. ALL RESULTS ARE IN UMOL/L. THE INITIAL RESULT WAS 325.8 WITH A FLAG AND THE REPEAT RESULT ON THE COBAS C311 ANALYZER (NO SERIAL NUMBER PROVIDED) WAS 78.0. THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER AND THE RESULTS WERE 77.7 WITH A FLAG AND 80.1. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE. THE AMMONIA REAGENT LOT NUMBER WAS 62961001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER JIF ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1