BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 8744590 · Received June 28, 2019

    Report

    Report Number
    1823260-2019-02372
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    June 12, 2019
    Report Date
    June 28, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QC RESULTS WERE ACCEPTABLE AND GAVE NO INDICATION OF A REAGENT OR INSTRUMENT ISSUE. THE CUSTOMER STATED THAT THEY DID NOT HAVE ANY OTHER TESTS WITH ANY QUESTIONABLE RESULTS. THE FIELD ENGINEERING SPECIALIST WAS UNABLE TO FIND A SPECIFIC ROOT CAUSE. HE SUSPECTED A VALVE FAILURE ALONG THE SAMPLING FLOW PATH. HE REPLACED THE FOLLOWING ITEMS: DOSAGE SYRINGES, PIPETTOR MODULE VALVES, PRESSURE SENSORS, AND TRANSFER HEAD VALVES. HE RAN A CALCIUM PRECISION TEST AND QC TESTING WITH ACCEPTABLE RESULTS. THE CUSTOMER RAN QC WITH ACCEPTABLE RESULTS. NO FURTHER ISSUES FOLLOWING THE SERVICE VISIT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE CA2 CALCIUM GEN.2 RESULT FOR 2 PATIENTS TESTED ON A COBAS INTEGRA 400 PLUS. FOR PATIENT 1: THE INITIAL CA2 RESULT WAS 12.9 MG/DL. THE SAME PATIENT SAMPLE WAS TESTED ON ANOTHER INTEGRA 400 PLUS WITH A RESULT OF 9.6 MG/DL. THE SAME PATIENT SAMPLE WAS SENT TO AN OUTSIDE LABORATORY AND TESTED ON A COBAS 6000 ANALYZER WITH A RESULT OF 9.8 MG/DL. FOR PATIENT 2: THE INITIAL CA2 RESULT WAS 11.7 MG/DL. THE SAME PATIENT SAMPLE WAS TESTED ON ANOTHER INTEGRA 400 PLUS WITH A RESULT OF 9.3 MG/DL. PATIENT 2 IS AN (B)(6) MALE BORN ON (B)(6). THE RESULTS IN QUESTION WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ADVERSE EVENT. THE CA2 REAGENT LOT IS 4033010 WITH AN EXPIRATION DATE OF 30-JUN-2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537552 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS I400+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR