BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1585446 · Received January 15, 2010

    Report

    Report Number
    1823260-2010-00279
    Event Type
    Malfunction
    Date Received
    January 15, 2010
    Date of Event
    December 30, 2009
    Report Date
    March 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLB
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS A KNOWN OFF SET OF AROUND 10 U/L BETWEEN THE TWO METHODS WHICH CONTRIBUTES TO THE BIAS. THE BIAS OBSERVED BY THE CUSTOMER WHEN COMPARING CK ON THE I800 AND C501 ANALYZERS IS MOST SIGNIFICANT IN THE LOW END OF THE NORMAL RANGE OF THE ASSAY AND IS NOT CLINICALLY SIGNIFICANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT OPERATE ON BATTERY POWER. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Description of Event or Problem · 1

    USER RECEIVED LOWER CK RESULTS COMPARED TO RESULTS OBTAINED FROM THEIR COBAS 6000 ANALYZER DURING AN INSTRUMENT CORRELATION STUDY. FIVE PATIENT SAMPLES WERE USED TO PERFORM THE CORRELATION STUDY OF WHICH ONLY THE FOLLOWING PATIENT SAMPLE WAS DISCREPANT. INITIAL RESULT FROM INTEGRA 800 GAVE 34 COMPARED TO 46 U/L FROM THE COBAS 6000 ANALYZER. USER SAID NONE OF THE INTEGRA RESULTS WERE REPORTED OUT. PATIENTS NOT ADVERSELY AFFECTED. CUSTOMER LOADED A NEW LOT OF CK REAGENT ON BOARD THE ANALYZER WHICH THEN GENERATED CK RESULTS COMPARABLE TO THE CK RESULTS FROM THE COBAS 6000. CUSTOMER INDICATED THE ISSUE WAS RESOLVED WITH THE NEW LOT OF CK REAGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER - JJE JLB ROCHE DIAGNOSTICS I800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK