BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR PRE ANALYTICS

    MDR report key: 3813481 · Received May 15, 2014

    Report

    Report Number
    1823260-2014-03450
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 15, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN THE (B)(6).

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THE RACK TRAY WAS MORE THAN TEN YEARS OLD AND A DESIGN CHANGE OCCURRED IN 2005 TO ROUND THE EDGES OF THE TRAY. THIS WAS COMMUNICATED VIA A SERVICE BULLETIN. THIS WAS THE ONLY COMPLAINT RECEIVED SINCE THE DESIGN CHANGE.

    Description of Event or Problem · 1

    THE CUSTOMER WAS UNLOADING RACKS FROM THE OUTPUT BUFFER MODULE OF THEIR MPA. WHILE REMOVING THE 25 RACK TRAY FROM THE MODULE, HE WAS HOLDING ONTO THE END WITH THE TWO LOCATING PRONGS. HE "PUT A TEAR" INTO THE END OF HIS FINGER. HE WENT TO THE A/E TO HAVE IT CLEANED AND GLUED AS IT WAS BLEEDING FREELY. HE THEN WENT TO THE HOSPITAL'S OCCUPATIONAL HEALTH DEPARTMENT TO HAVE A BLOOD SAMPLE TAKEN. THE RESULTS CAME BACK ALL CLEAR. THE FINGER WAS HEALING WELL, THERE WERE NO ADVERSE AFFECTS, AND NO FURTHER TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290125 MODULAR PRE ANALYTICS AUTOMATED PREANALYTICAL SYSTEM JQP ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR Other