BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSD 1200

    MDR report key: 1962451 · Received January 18, 2011

    Report

    Report Number
    1823260-2011-00258
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 28, 2010
    Report Date
    May 5, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THE EXPLOSION OF THE FRONT COVER WAS CAUSED BY MECHANICAL STRESS TO THE GLASS DOOR DUE TO A WEAK GAS PRESSURE SPRING OR OTHER MECHANICAL INFLUENCE, WHICH OCCURS ONLY WHEN THE PREVENTIVE MAINTENANCE WAS NOT PERFORMED PROPERLY. ACCORDING TO THE PREVENTIVE MAINTENANCE SCHEDULE, THE GAS PRESSURE SPRING SHOULD BE CHECKED EVERY THREE MONTHS AND REPLACED AS NEEDED. THE GLASS DOOR IS MADE OF "SECURITY GLASS" WHICH IS TEMPERED, CREATING TENSION INSIDE THE GLASS ITSELF. THE PURPOSE OF THIS INTERNAL TENSION IS THAT, IN CASE OF BREAKAGE, THE GLASS BREAKS INTO SMALL PIECES, TOO SMALL TO CREATE SERIOUS CUTS.

    Description of Event or Problem · 1

    THE OPERATOR STATED THE GLASS FRONT ON THE COVER OF THE PRIMARY SAMPLE DISTRIBUTION SYSTEM (PSD) EXPLODED WHILE THE COVER WAS BEING OPENED AND STATED IT "LOOKED LIKE A ROCK WAS THROWN THROUGH A WINDOW." HE SAID HE HAD LIFTED THE COVER ABOUT 3 TO 4 INCHES WHEN THE GLASS SHATTERED AND HE WAS STILL HOLDING THE COVER IN THAT SPOT WHEN ALL THE GLASS HAD FALLEN. THE OPERATOR'S LEFT HAND WAS CUT MULTIPLE TIMES WITH SEVERAL SMALL CUTS AND SCRATCHES. NO TREATMENT WAS RECEIVED FROM A HEALTHCARE PROVIDER AND THE OPERATOR FOLLOWED THE LABORATORY'S PROTOCOL FOR INJURY. HE BANDAGED HIS HAND AND WENT BACK TO WORK. HIS CURRENT CONDITION WAS GIVEN AS "FINE". THE FIELD SERVICE REPRESENTATIVE REPLACED THE FRONT GLASS PART OF THE PSD COVER AND VERIFIED THE OPERATION OF THE COVER BY OPENING AND CLOSING IT SEVERAL TIMES WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSD 1200 PRIMARY SAMPLE DISTRIBUTION SYSTEM JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1