BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3147294 · Received June 5, 2013

    Report

    Report Number
    1823260-2013-03387
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 23, 2013
    Report Date
    August 13, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE PROVIDED DATA, THE INVESTIGATION DETERMINED THE LOW CALIBRATION SIGNALS WERE THE MOST LIKELY REASON FOR THE DISCREPANT PATIENT RESULTS. A GENERAL ISSUE WITH FOLATE REAGENT LOT 171579 CAN BE EXCLUDED AS CALIBRATION WITH A NEW REAGENT KIT GENERATED THE CORRECT SIGNAL LEVEL. IT WAS NOTED THE QC LOT IN USE AT THE TIME OF THE EVENT WAS EXPIRED. THIS CONTROL WAS THEREFORE NOT SUITABLE FOR VALIDATION OF RUNS AND RELEASE PATIENT RESULTS. NO SERIOUS ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED DOCUMENTING THE REPEAT TESTING WAS PERFORMED ON (B)(4) 2013. THE CUSTOMER STATED IT WAS UNKNOWN IF THE PHYSICIAN REPORTED A FALSE DIAGNOSIS AS A CONSEQUENCE OF THE RESULT. AMENDED REPORTS WERE SENT THE FOLLOWING DAY AND NO ADVERSE EVENT WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE LOW FOLATE RESULTS FOR 53 PATIENT SAMPLES. OF THE DATA PROVIDED, ONLY THE RESULTS FOR 28 PATIENT SAMPLES WERE DISCREPANT. ALL OF THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NONE OF THE PATIENTS WERE ADVERSELY AFFECTED. THE FOLATE REAGENT LOT NUMBER WAS 171579. THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248177 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1