BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1666226 · Received April 23, 2010

    Report

    Report Number
    1823260-2010-02449
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Date of Event
    April 8, 2010
    Report Date
    April 23, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER RECEIVED ERRONEOUS RESULTS FOR FIVE PATIENT SAMPLES. OF THE DATA PROVIDED, THE RESULTS FOR THREE SAMPLES WERE DISCREPANT. ALL REPEAT TESTING WAS PERFORMED ON (B) (6) 2010. SAMPLE 1 INITIAL SODIUM RESULT WAS 134 MMOL/L, REPEATED RESULTS WERE 129, 114, 135, 135, 135, 134 AND 128 MMOL/L. SAMPLE 2 INITIAL CALCIUM RESULT WAS 10.14 MG/DL, REPEAT RESULTS WERE 9.25, 9.26, 9.20, 9.35 AND 9.27 MG/DL. INITIAL GLUCOSE RESULT WAS 298 MG/DL, REPEAT RESULTS WERE 132, 132, 133, 131, 132, 132, 132, 133, 133 AND 132 MG/DL. SAMPLE 3 INITIAL CALCIUM RESULT WAS 10.12 MG/DL, REPEAT RESULTS WERE 9.22, 9.27, 9.22, 9.28, 9.30 MG/DL. INITIAL GLUCOSE RESULT WAS 196 MG/DL, REPEAT RESULTS WERE 88, 87, 87, 87, 88, 88, 88, 87, 87 AND 87 MG/DL. THE ERRONEOUS RESULTS WERE REPORTED. THE USER DID NOT KNOW IF ANY PATIENTS WERE TREATED AND HAD NO ACCESS TO INFORMATION REGARDING PATIENT CURRENT CONDITION. THE LOT NUMBER OF THE SODIUM ELECTRODE WAS NOT PROVIDED. THE REAGENT LOT NUMBERS WERE CALCIUM 61691701 AND GLUCOSE 61774601. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH DOSAGE B PIPETTE. HE PERFORMED A CHECK TEST, REPLACED THE DOSAGE PIPETTE B AND SWITCHED THE DOSAGE VALVES. TO VERIFY THE ANALYZER OPERATION, HE RAN A 10 POINT PRECISION TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1