BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 3873867 · Received June 16, 2014

    Report

    Report Number
    1823260-2014-04346
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    June 2, 2014
    Report Date
    July 25, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL DATA WERE REQUESTED BUT NOT PROVIDED. THE CALIBRATION AND QUALITY CONTROL RESULTS WERE ACCEPTABLE AT THE TIME OF THE EVENT, AND A GENERAL REAGENT ISSUE WAS EXCLUDED. NO OTHER TESTS WERE AFFECTED. A PROBLEM WITH THE ANALYZER ROTOR WOULD SHOW A DIFFERENT ERROR PATTERN. THE INITIALIZATION PROCESS CHECKS THE ROTOR ACCURACY AND VISUALLY INSPECTS CUVETTES. ERROR MESSAGES WOULD ALERT THE USER THERE WERE ISSUES. THE HARDWARE ISSUE AS A ROOT CAUSE WAS EXCLUDED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE CALCIUM GEN2 RESULTS ON THEIR INTEGRA 400 PLUS ANALYZER. THE CUSTOMER ALLEGED THERE WERE TWO INCIDENTS IN A COUPLE OF MONTHS WITH HIGH CALCIUM RESULTS ON PATIENT SAMPLES THAT REPEATED LOWER. THE CUSTOMER WAS ONLY ABLE TO PROVIDE DATA FOR ONE PATIENT WITH A DISCREPANT RESULT. THE CUSTOMER STATED ALL THE OTHER RESULTS FROM THE SAMPLE WERE NORMAL. THE PATIENT'S INITIAL CALCIUM RESULT WAS 15.7 MG/DL ACCOMPANIED BY A DATA FLAG. THE INITIAL RESULT WAS CALLED TO THE PHYSICIAN DUE TO IT BEING A CRITICAL RESULT. THE PHYSICIAN ASKED FOR THE TEST TO BE REPEATED, AND THE REPEAT RESULTS WERE THEN CALLED TO THE PHYSICIAN. THE REPEAT RESULTS WERE 9.98 MG/DL AND 9.84 MG/DL. THE PATIENT WAS NOT TREATED AND THERE WERE NO ADVERSE EVENTS. THE CALCIUM REAGENT LOT NUMBER WAS 69275401 AND THE EXPIRATION DATE WAS 12/31/2014. THE FIELD SERVICE REPRESENTATIVE CHECKED THE SYSTEM AND FOUND THAT THE WORKSTATION ROTOR WAS OUT OF ADJUSTMENT. HE ADJUSTED THE ROTOR. HE RAN DIAGNOSTIC CHECKS, QUALITY CONTROL, AND A PRECISION CHECK AND ALL WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352058 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1