BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 3113518 · Received May 15, 2013

    Report

    Report Number
    1823260-2013-02961
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 22, 2013
    Report Date
    August 19, 2013
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. IT WAS NOTED THAT THE CENTRIFUGATION TIME WAS VERY SHORT AND THAT THE PATIENT'S DIAGNOSIS CAN LEAD TO VERY HIGH ALP RESULTS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER TREATMENT. THIS TRANSFER WAS NOT AS A RESULT OF THE ERRONEOUS RESULTS. NO ADDITIONAL INFORMATION ABOUT THE FURTHER TREATMENT WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. FOR MEDWATCH ON ERRONEOUS ALK RESULTS WITH COBAS INTEGRA 400+ ANALYZER SERIAL NUMBER (B)(4), PLEASE REFER TO MEDWATCH WITH (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ALP IFCC GEN. 2 (ALK) ON ONE PATIENT SAMPLE. ALL RESULTS ARE IN U/L. THE PATIENT HAD AN INITIAL ALK RESULT OF 45, USING A DILUTION. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS RUN ON ANOTHER COBAS INTEGRA 400+ ANALYZER SERIAL NUMBER 39-9062. THE SAMPLE GENERATED A REPEAT RESULT OF 41, USING A DILUTION AND 2383, USING A DILUTION. IT IS UNKNOWN WHAT RESULT THE CUSTOMER DEEMED TO BE THE CORRECT RESULT. THERE WAS NO ADVERSE EVENT. THE LOT OF ALK REAGENT IN USE WAS 66863401, WITH AN EXPIRATION DATE OF 05/31/2013. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE AN ISSUE WITH THE PATIENT SAMPLE. HE COULD NOT FIND A SAMPLE IN THE RANGE OF THE SAMPLE IN QUESTION. NO SAMPLE WAS AVAILABLE FOR RE-TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215521 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 016 YR