BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1891281 · Received November 4, 2010

    Report

    Report Number
    1823260-2010-06589
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 14, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. THE REACTION KINETICS FROM THE ANALYZER WERE PROVIDED FOR INVESTIGATION. THE REACTION KINETICS AT THE TIME THE PATIENT SAMPLE WAS RUN INDICATE THE ISSUE WAS MOST PROBABLY CAUSED BY PREANALYTICAL INTERFERENCES, SUCH AS PARTICULATE MATTER, FIBRIN, MICROCLOTS, CELLS OR PLATELETS. IT WAS ALSO NOTED THE CUSTOMER SHOULD BE CLEANING THE SAMPLE PROBE MORE OFTEN. IN ADDITION, A CALIBRATION ISSUE OR CO2 UPTAKE OF THE SAMPLES PRIOR TO THE RUN IS ALSO A POTENTIAL CAUSE. IT WAS RECOMMENDED THE LABORATORY CHECK THE CO2 CONCENTRATION IN THE LAB.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR PATIENT SAMPLES AND REPEATED TESTING ON (B)(6) 2010. THE USER STATED 10 OF THE RESULTS DID NOT MATCH TO HER SATISFACTION AND PROVIDED DATA FOR SIX PATIENT SAMPLES. OF THE PROVIDED DATA, THE RESULTS FOR TWO OF THE SAMPLES WERE DISCREPANT. PATIENT SAMPLE 1 INITIAL BICARBONATE RESULT WAS 36.6 MMOL/L AND THE REPEAT RESULTS WERE 25.7 WAS 24.3 MMOL/L. THE INITIAL GLUCOSE RESULT WAS 207 MG/DL AND THE REPEAT RESULT WAS 104 MG/DL. THE INITIAL CALCIUM RESULT WAS 9.5 MG/DL AND THE REPEAT RESULT WAS 8.4 MG/DL. PATIENT SAMPLE 2 WAS FROM A FEMALE BORN ON (B)(6). THE INITIAL BICARBONATE RESULT WAS 36.7 MMOL/L WITH A DATA FLAG AND THE REPEAT RESULTS WERE 25.7 AND 24.5 MMOL/L. THE INITIAL RESULTS HAD BEEN REPORTED OUTSIDE THE LABORATORY. THE USER STATED SHE KNOWS THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE BICARBONATE REAGENT LOT NUMBER WAS 62804201, GLUCOSE WAS 63035301 AND CALCIUM WAS 62802801. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A HARDWARE CAUSE AND CHECKED THE ENTIRE SYSTEM. HE OBSERVED PROPER FUNCTION DURING PRECISION TESTING ON THE PATIENT SAMPLES AND RAN PERFORMANCE TESTS. ALL THE RESULTS WERE WITHIN SPECIFICATION AND WITHIN THE ACCEPTABLE RANGE.

    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
    1 085 YR