BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 2377413 · Received December 15, 2011

    Report

    Report Number
    1823260-2011-06737
    Event Type
    Malfunction
    Date Received
    December 15, 2011
    Date of Event
    December 5, 2011
    Report Date
    December 15, 2011
    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
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE C-REACTIVE PROTEIN LATEX 3 (CRP) RESULTS ON THEIR INTEGRA 400 PLUS ANALYZER. THE CUSTOMER PULLED A REPORT OF CRP RESULTS THAT HAVE BEEN REPORTED SINCE THE (B)(6) 2011 WHEN THEY WENT LIVE WITH THE ASSAY. THERE WERE 52 CRP RESULTS AND A SMALL NUMBER OF THEM WILL NEED TO HAVE THE PHYSICIANS ALERTED THAT THEY ARE INACCURATE. THE CUSTOMER STATED MOST OF THE RESULTS WERE WITHIN THE NORMAL LIMIT EVEN THOUGH THEY ARE BELIEVED TO BE TEN-FOLD HIGHER THAN THEY SHOULD HAVE BEEN. THE CUSTOMER PROVIDED DATA FOR SIX PATIENTS, OF WHICH ONE PATIENT HAD DISCREPANT RESULTS REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S INITIAL CRP RESULT WAS 3.9 MG/DL. IT WAS DISCOVERED THAT WHEN THE APPLICATION WAS INSTALLED BY THE FIELD SERVICE REPRESENTATIVE, THE CALIBRATION SET POINTS FOR THE REAGENT LOT THE CUSTOMER HAS BEEN USING WERE INCORRECTLY SET AS MG/L. THE LABORATORY UNIT FACTOR WAS SET TO REPORT RESULTS IN MG/DL. FOR ONE OF THE QUALITY CONTROL MATERIALS, THE PEER MEAN RESULT WAS 0.59 MG/DL AND THE CUSTOMER SET THEIR QUALITY CONTROL MEAN AT 0.6 MG/DL. OF THE OTHER QUALITY CONTROL MATERIAL, THE PEER MEAN WAS 4.73 MG/DL, AND THE CUSTOMER SET THEIR QUALITY CONTROL MEAN AT 44.9 MG/L. THE CUSTOMER CORRECTED THE CALIBRATION VALUES, RECALIBRATED, REPEATED QUALITY CONTROL, AND REPEATED THE PATIENT'S SAMPLE. THE REPEAT RESULT WAS 0.4 MG/DL FROM THE SAME INTEGRA 400 PLUS ANALYZER. THE CUSTOMER CONFIRMED THAT NO TREATMENT WAS GIVEN BASED ON THE INITIAL, ERRONEOUS RESULT OF 3.9 MG/DL. THERE WERE NO ADVERSE EVENTS. THE CRP REAGENT LOT NUMBER WAS 64229501 AND THE EXPIRATION DATE WAS (B)(6) 2013. THE CUSTOMER STATES THE VALUES ARE NOW CORRECT.

    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
    1 034 YR