BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 2220456 · Received August 23, 2011

    Report

    Report Number
    1823260-2011-04497
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 21, 2011
    Report Date
    September 9, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED NEW INFORMATION REGARDING THE PATIENTS, DOCUMENTING ALL THE PATIENTS WERE ADULTS. THE APPLICATION SPECIALIST CONFIRMED NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND NO PATIENTS WERE HARMED BY ANY ACTION TAKEN.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED CARRY-OVER CAUSED THE OBSERVED ISSUE. THE PROBLEM WAS RESOLVED BY IMPLEMENTING A SPECIAL WASH BEFORE THE CREATININE TEST AND MOVING CREATININE TO BE THE INITIAL TEST PERFORMED. THIS WAS DEEMED A LABORATORY AND INSTRUMENT SPECIFIC ISSUE. NO ADVERSE EVENT WAS REPORTED AND NO FALSE TREATMENT WAS ADMINISTERED.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    NEW INFORMATION RECEIVED IDENTIFIED THE FOLLOWING DATA AS DISCREPANT CREATININE RESULTS FOR AN ADDITIONAL PATIENT SAMPLE: THE INITIAL CREATININE RESULT, GENERATED (B)(4) 2011, WAS 111.620 UMOL/L. THE SAMPLE WAS REPEATED THREE TIMES AND RECOVERED 76.532 UMOL/L, 78.151 UMOL/L AND 91.019 UMOL/L. IT IS UNKNOWN IF THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS HAVE BEEN ALLEGED REGARDING THE DISCREPANCIES.

    Description of Event or Problem · 1

    THE CUSTOMER HAD AN ON-GOING ISSUE WITH CREATININE RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES. WHEN THE CUSTOMER OBSERVED HIGH CREATININE VALUES, THEY REPEATED THE SAMPLES AND RECEIVED VERY DIFFERENT RESULTS. THE ANALYZER'S HALOGEN LAMP WAS OVERDUE FOR REPLACEMENT AND WAS REPLACED ON (B)(6) 2011. THE CUSTOMER CONTINUED TO RECEIVE 1-2 ELEVATED CREATININE RESULTS PER DAY WHICH REPEATED "NORMAL." THE CUSTOMER PROVIDED DISCREPANT CREATININE RESULTS FOR FIVE PATIENT SAMPLES. PATIENT 1, INITIAL RESULT WAS 120.856 UMOL/L. THE SAMPLE WAS REPEATED AND RECOVERED 91.715 UMOL/L. PATIENT 2, FEMALE, INITIAL RESULT WAS 110.446 UMOL/L. THE SAMPLE WAS REPEATED TWICE AND RECOVERED 65.745 UMOL/L AND 64.631 UMOL/L. PATIENT 3, FEMALE, TESTED (B)(6) 2011, INITIAL RESULT WAS 91.774 UMOL/L. THE SAMPLE WAS REPEATED AND RECOVERED 53.311 UMOL/L. PATIENT 4, MALE, TESTED (B)(6) 2011, INITIAL RESULT WAS 146.640 UMOL/L. THE SAMPLE WAS REPEATED AND RECOVERED 86.746 UMOL/L. PATIENT 5, FEMALE, TESTED (B)(6) 2011, INITIAL RESULT WAS 140.112 UMOL/L. THE SAMPLE WAS REPEATED TWICE AND RECOVERED 59.478 UMOL/L AND 57.542 UMOL/L. IT IS NOT KNOWN IF THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS HAVE BEEN ALLEGED REGARDING THE DISCREPANCIES. THE CREATININE REAGENT WAS CREATININE PLUS VERSION 2, LOT NUMBER 640244- 01.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1