BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1513447 · Received July 6, 2009

    Report

    Report Number
    1823260-2009-04697
    Event Type
    Malfunction
    Date Received
    July 6, 2009
    Date of Event
    June 4, 2009
    Report Date
    July 6, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REP DETERMINED THERE WAS CONTAMINATION AND DECONTAMINATED THE REAGENT LINE CHANNEL FOR BICARBONATE. HE ALSO FOUND THE REAGENT RINSE STATION WAS NOT DISPENSING THE RINSE, THE STIR RINSE WAS LOW AND THE RINSE BATH WAS DIRTY. HE ALSO FOUND THE MSV WAS WORN AND DIRTY AND THE HITERGENT WAS YELLOW IN COLOR. HE ADJUSTED THE RINSE STIR AND REAGENT NOZZLES, CLEANED THE GENERAL AREA, CLEANED THE MSV AND REPLACED THE HITERGENT BOTTLE AND PRIMED THE REAGENT. TO VERIFY THE ANALYZER PERFORMANCE, CALIBRATION AND QC WERE PERFORMED WITH ALL RESULTS WITHIN SPECIFICATION. (B) (6).

    Description of Event or Problem · 1

    THE USER HAD NOTED A DRIFT IN QC VALUES FOR BICARBONATE SINCE (B) (6) 2009. HE ALSO STATED DOCTORS DID NOT BELIEVE THE BICARBONATE RESULTS GENERATED FROM MULTIPLE D MODULES AT THIS SITE AND EXPERIENCED LOW RESULTS FOR THEIR PTS. THE PTS WERE REDRAWN AND THE NEW SAMPLE WAS RUN AT ANOTHER FACILITY WHERE THE BICARBONATE RESULTS WOULD BE NORMAL. THE USER DID NOT SUPPLY INFO AS TO WHAT RESULTS THE DOCTOR CONSIDERED TO BE NORMAL. THE USER COULD NOT PROVIDE ANY PT BICARBONATE RESULTS AND STATED THAT MULTIPLE RESULTS WERE QUESTIONED AND THEY COULD NOT DETERMINE WHICH D MODULE PRODUCED THE ERRONEOUS RESULTS. IT IS UNK IF ANY PTS WERE ADVERSELY AFFECTED DUE TO THE ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL D MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK