BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 3111096 · Received May 14, 2013

    Report

    Report Number
    1823260-2013-02912
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 24, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE CREJ REAGENT LOT NUMBER WAS 675264 FOR BOTH ANALYZERS.

    Additional Manufacturer Narrative · 1

    AN I INDEX OF 44 WAS CALCULATED FOR THE PATIENT SAMPLE, WHICH IS MUCH HIGHER THAN THE ICTERUS INDEX LIMIT OF 5 CLAIMED IN THE INTEGRA LABELING. UNLIKE THE COBAS C501, THE INTEGRA CANNOT PERFORM A RATE- BLANKING OF THE SAMPLE TO COMPENSATE FOR THE HIGH BILIRUBIN CONTENT. THIS ANALYZER DIFFERENCE EXPLAINS THE DIFFERENCE SEEN IN THE CREJ RECOVERY BETWEEN THE ANALYZERS. THE BILIRUBIN(ICTERUS) LIMITATION IS DOCUMENTED IN PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6). NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE CREATININE JAFFÉ GEN.2 (CREJ) RESULTS FOR ONE PATIENT ON THEIR INTEGRA 400 ANALYZER. THE PATIENT'S INITIAL CREJ RESULT WAS 0.31 MG/DL AND IT WAS REPORTED OUTSIDE THE LABORATORY. A FEW HOURS LATER, THE LABORATORY RECEIVED A SECOND SAMPLE FROM THE PATIENT TO DETERMINE THE CREJ VALUE. THE SAMPLE WAS TESTED ON A COBAS C501, SERIAL NUMBER NOT PROVIDED, AND THE RESULT WAS 1.2 MG/DL. THE LABORATORY RECEIVED A COMPLAINT ABOUT THE DISCREPANT RESULTS FROM THE PHARMACY DEPARTMENT. BOTH OF THE SAMPLES WERE REPEATED ON THE ANALYZERS THEY WERE INITIALLY TESTED ON AND CONFIRMED THE INITIAL RESULTS. THE INTEGRA 400 GAVE A RESULT OF 0.3 MG/DL AND THE C501 GAVE A RESULT OF 1.2 MG/DL. THE INITIAL SAMPLE WAS REPEATED IN THE C501 ANALYZER AND THE RESULT WAS 1.28 MG/DL. THE SECOND SAMPLE WAS TESTED IN THE INTEGRA 400 AND THE RESULT WAS 0.3 MG/DL. THE CUSTOMER ALSO PROVIDED DATA FROM (B)(6) 2013 ON THE C501 FOR THE FIRST SAMPLE AND THE RESULT WAS 1.36 MG/DL. THE DOCTOR CONSIDERED THE CORRECT RESULT TO BE 1.2 MG/DL. ON (B)(6) 2013, THE PATIENT HAD ANOTHER SAMPLE DRAWN. IT WAS TESTED IN THE INTEGRA 400 ANALYZER AND THE RESULT WAS 0.31 MG/DL AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED IN THE C501 ANALYZER AND THE RESULT WAS 1.38 MG/DL. THE DISCREPANT RESULTS WERE NOT BELIEVED AND THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE CREJ REAGENT LOT NUMBER WAS EITHER 680931 WITH AN EXPIRATION DATE OF 12/31/2014 OR 675264 AND THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212726 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR TRIAPIZOL + TRANSILIUM| BENZODIACEPINAS| FUROSEMIDA| VANCOMICINA| SEGURIL| CEFTRIAXONA