BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1884163 · Received October 27, 2010

    Report

    Report Number
    1823260-2010-06382
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 11, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LCD
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER OF THE AFFECTED SAMPLES NOR THE RAW DATA FROM THE MEASUREMENTS IN QUESTION WERE AVAILABLE FOR INVESTIGATION. THE SPECIFC ROOT CAUSE COULD NOT BE DETERMINED. THE PATIENTS WERE NOT ADVERSELY AFFECTED.

    Description of Event or Problem · 1

    A CUSTOMER RECEIVED DISCREPANT GENTAMICIN RESULTS FOR TWO PATIENT SAMPLES. INITIAL AND REPEAT TESTING WERE PERFORMED ON THE SAME COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER. PATIENT 1, INITIAL GENTAMICIN RESULT WAS 4.0 UG/ML. THE SAME SAMPLE REPEATED GAVE 0.7 UG/ML. PATIENT 2, INITIAL GENTAMICIN RESULT WAS 1.1 UG/ML. THE SAME SAMPLE REPEATED GAVE 0.6 UG/ML. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PHYSICIANS CALLED AND STATED THE PATIENTS HAD NOT BEEN "DOSED" YET AND QUESTIONED THE INITIAL GENTAMICIN RESULTS. THE PATIENTS WERE NOT TREATED BASED ON THE INITIAL RESULTS. THE GENTAMICIN REAGENT LOT NUMBER WAS 62136501. THE FIELD SERVICE REPRESENTATIVE DID NOT DETERMINE THE CAUSE OF THE DISCREPANCIES. HE PERFORMED MAINTENANCE, CLEANING, PERFORMANCE CHECKS AND QUALITY CONTROL.

    Description of Event or Problem · 1

    RECEIVED INFORMATION FROM MEDTRONIC REPRESENTATIVE REPORTING TELEMETRY PROBLEMS WITH THE INS. THE INS WAS UNRESPONSIVE TO TELEMETRY ATTEMPTS BY THE PHYSICIAN AND PATIENT PROGRAMMERS, AS WELL AS THE RECHARGER. USING THE ANTENNA LOCATE FEATURE RESOLVED THE TELEMETRY ISSUE AND RESULTED IN A POWER ON RESET CONDITION ON THE RECHARGER'S SCREEN. MEDTRONIC REPRESENTATIVE WAS ATTEMPTING TO CLEAR THE POWER ON RESET. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER LCD ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1