BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3021755 · Received March 26, 2013

    Report

    Report Number
    1823260-2013-01854
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 2, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE AS THE CUSTOMER REFUSED TO PROVIDE ANY FURTHER INFORMATION.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE C-REACTIVE PROTEIN GENERATION 3 (CRP) RESULT FOR ONE PATIENT SAMPLE. THE CUSTOMER REFERENCED COBAS C501 SERIAL NUMBER (B)(4), BUT WAS NOT CERTAIN IF THIS WAS THE ANALYZER USED FOR TESTING. A SAMPLE FROM THE PATIENT WAS ORIGINALLY TESTED AT ANOTHER SITE ON COBAS C501 SERIAL NUMBER (B)(4) ON (B)(6) 2013 WITH A RESULT OF 3.06 MG/DL. THE LABORATORY DID NOT BELIEVE THIS RESULT AND SENT A SAMPLE TO THIS LABORATORY FOR REPEAT TESTING. ON (B)(6) 2013, THE INITIAL RESULT ON COBAS C501 SERIAL NUMBER (B)(4) WITH A DIFFERENT TUBE FROM THE SAME DRAW WAS <0.1 MG/DL. THIS RESULT WAS REPORTED TO THE ORIGINAL LABORATORY AND WAS REPORTED OUT. ON (B)(6) 2013, THE OTHER SITE RETESTED THE SAMPLE THAT ORIGINALLY GENERATED THE RESULT OF 3.06 MG/DL AND THE RESULTS WERE 3.02 AND 3.20 MG/DL. ON (B)(6) 2013, THE ORIGINAL SITE SENT ANOTHER SAMPLE FROM THE PATIENT TO THIS LABORATORY AND THE RESULT FOR THAT SAMPLE WAS 2.42 MG/DL. ON (B)(6) 2013, THE LABORATORY REPEATED THE ORIGINAL TUBE WHICH HAD GENERATED THE RESULT OF <0.1 MG/DL AND THE RESULTS WERE 2.45 AND 2.60 MG/DL. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CRP REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE CUSTOMER REFUSED A SERVICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124284 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1