BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 7710182 · Received July 23, 2018

    Report

    Report Number
    1823260-2018-02434
    Event Type
    Malfunction
    Date Received
    July 23, 2018
    Date of Event
    July 5, 2018
    Report Date
    October 19, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924592
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    QUESTION FROM FDA: IN YOUR RESPONSE, YOU HAVE INDICATED THAT "THE CUSTOMER HAS SUBSEQUENTLY CHANGED THE SAMPLE TUBES THEY WERE USING AND REMOVED THE EXTRA WASH CYCLE, AND NO FURTHER ISSUES HAVE OCCURRED." COULD YOU CLARIFY WHAT KIND OF SAMPLE TUBE WAS CHANGED? E.G. IS IT CHANGED FROM A LITHIUM HEPARIN PLASMA TUBE TO A SERUM TUBE, OR FROM A SPECIFIC MANUFACTURER SERUM TUBE TO A DIFFERENT MANUFACTURER FOR THE SAME TUBE TYPE? ANSWER: THE CUSTOMER WAS ORIGINALLY USING THE SARSTEDT S-MONOVETTE® 7.5 ML Z GEL, ORDER NO. 01.1602 TUBE. THE CUSTOMER HAS REPLACED THE GEL TUBES WITH THE SARSTEDT S-MONOVETTE® 7.5ML Z, ORDER NO. 01.1601 TUBE.

    Additional Manufacturer Narrative · 0

    INSTRUMENT MAINTENANCE WAS LAST PERFORMED ON (B)(6) 2018 AND WAS WITHIN SPECIFICATION. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION OF AN INSTRUMENT PROBLEM. THE CUSTOMER CHANGED THE SAMPLE TUBES THEY WERE USING AND NO FURTHER ISSUES OCCURRED. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    MDR 1823260-2018-02434. CUSTOMER WAS HAVING ISSUES WITH FALSE HIGH CREATININE RESULTS ON THE INTEGRA 400 PLUS ANALYZER AND ISSUES WERE RESOLVED AFTER CUSTOMER HAS IMPLEMENTED AN EXTRA WASH CYCLE. IS THE ISSUE THAT THE CUSTOMER HAVING THE SAME ISSUES AS THE ONE REPORTED IN 1823260-2018-00798. IF NOT, PLEASE EXPLAIN IN DETAIL WHAT THE ROOT CAUSE OF THE FALSE ERRONEOUS RESULTS AND YOUR INVESTIGATION. THE ISSUE IS NOT THE SAME AS THE ISSUE REPORTED IN 1823260-2018-00798. THE CAUSE WAS MOST LIKELY A PROBLEM WITHIN THE SAMPLE TUBE HANDLING AND NOT THE EXTRA WASH CYCLE (EWC). THE CUSTOMER HAS SUBSEQUENTLY CHANGED THE SAMPLE TUBES THEY WERE USING AND REMOVED THE EXTRA WASH CYCLE, AND NO FURTHER ISSUES HAVE OCCURRED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS NOT HAD ANY ADDITIONAL ISSUES WITH CREP2 RESULTS. THEY ARE REPEATING ALL PATIENT SAMPLES WITH HIGH RESULTS AND THEY HAVE ALL BEEN REPRODUCIBLE.

    Description of Event or Problem · 1

    THE CUSTOMER HAS BEEN HAVING INTERMITTENT ISSUES WITH PATIENTS TESTED FOR CREP2 CREATININE PLUS VER.2 (CREP2) ON A COBAS INTEGRA 400 PLUS FOR APPROXIMATELY 1 YEAR. THE CUSTOMER IMPLEMENTED AN EXTRA WASH CYCLE AND, FOR APPROXIMATELY 2 WEEKS, THE ISSUE WAS RESOLVED. HOWEVER, THE CUSTOMER HAS SINCE HAD SPORADIC ISSUES WITH QUESTIONABLE CREP2 RESULTS OCCURRING APPROXIMATELY 3 TIMES PER WEEK. THE CUSTOMER PROVIDED RECENT DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED FOR CREP2. PATIENT 1 INITIAL CREP2 RESULT WAS 2.21 MG/DL. THE REPEAT RESULT WAS 0.97 MG/DL. ON (B)(6) 2018 PATIENT 2 INITIAL CREP2 RESULT WAS 1.27 MG/DL. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 1.8 MG/DL AND 1.1 MG/DL. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CREP2 REAGENT LOT NUMBER WAS 32825201 WITH AN EXPIRATION DATE OF 31-DEC-2018. QC AND CALIBRATION WERE ACCEPTABLE. INSTRUMENT MAINTENANCE WAS LAST PERFORMED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552745 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS I400+ NA 04015630924592

    Patients

    Seq Age Sex Outcome Treatment
    1