BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 CU

    MDR report key: 5787017 · Received July 12, 2016

    Report

    Report Number
    1823260-2016-00895
    Event Type
    Malfunction
    Date Received
    July 12, 2016
    Date of Event
    June 24, 2016
    Report Date
    March 7, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ALSO NOTED THAT THE INVOLVED SAMPLE WAS QUITE YELLOW (ICTERIC). THE FIELD SERVICE REPRESENTATIVE COULD NOT DETECT ANY PROBLEMS WITH THE ANALYZER. HE BELIEVES THE ROOT CAUSE TO BE RELATED TO THE PATIENT SAMPLE SINCE IT WAS FOUND TO BE HEMOLYZED AND ICTERIC. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. AN INSTRUMENT OR REAGENT ISSUE CAN BE RULED OUT BECAUSE CALIBRATION AND QC ARE ACCEPTABLE AND THE INSTRUMENT WAS CHECKED TO BE OK. A POSSIBLE ROOT CAUSE MAY BE RELATED TO THE SAMPLE AS IT WAS FOUND TO BE HEMOLYZED AND ICTERIC. THE ROOT CAUSE MAY ALSO BE RELATED TO A CONTAMINATED SAMPLE PROBE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR CALCIUM GEN.2 (CA) ON A C501 ANALYZER AND AN INTEGRA 400 ANALYZER. ALL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. IT WAS STATED THAT THE INVOLVED SAMPLE WAS HEMOLYZED. THIS MEDWATCH WILL COVER THE INTEGRA 400 ANALYZER. PLEASE REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE C501 ANALYZER. THE SAMPLE INITIALLY RESULTED AS 11.11 MG/DL WHEN TESTED ON THE C501 ANALYZER. THE SAMPLE WAS REPEATED ON THE C501 ANALYZER, RESULTING AS 12.66 MG/DL. THE SAMPLE WAS REPEATED AGAIN ON THE C501 ANALYZER, RESULTING AS 10.01 MG/DL. THE SAMPLE WAS ALSO REPEATED ON THE INTEGRA 400 ANALYZER, RESULTING AS 9.90 MG/DL. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CA REAGENT LOT NUMBER WAS 152966, WITH AN EXPIRATION DATE OF 08/31/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441291 COBAS INTEGRA 400 CU CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS I400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1