BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPA

    MDR report key: 2011466 · Received March 9, 2011

    Report

    Report Number
    1823260-2011-01257
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 20, 2011
    Report Date
    September 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THE ISSUE WAS CAUSED BY A USER INTERFACE (B)(6) COMPUTER ISSUE. INVESTIGATION ON THE RETURNED PART REVEALED THAT A LARGER AMOUNT (MORE THAN A SPOONFUL) OF LIQUID HAD ENTERED THE DEVICE VIA THE AIR VENTILATION HOLE AT THE BACKSIDE. THIS LIQUID WETTED THE PRINTED CIRCUIT BOARDS WITH THE MAIN POWER CONNECTIONS OF THE POWER SUPPLY BEHIND THIS VENTILATION HOLE AND CAUSED SHORT CIRCUITS BETWEEN SEVERAL COMPONENTS OF THESE BOARDS. THE POWER SUPPLY WAS STRONG ENOUGH TO CAUSE SPARKS, SMOKE OR A BURNING SMELL BEFORE THE INTERNAL FUSES INTERRUPT THE CURRENT. SEVERAL ORIGINAL COMPONENTS WERE NOT AVAILABLE FOR FURTHER INVESTIGATION. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE USER REPORTED THE TOTAL SYSTEM MANAGER (TSM) "SPARKED" AND WOULD NOT POWER ON. WHEN THEY NOTICED THE SPARK, THE USER PULLED THE POWER SOURCE. THE USER WAS NOT SURE IF SMOKE WAS GENERATED, BUT THEY STATED "IT SMELLED FAINTLY". NO ERRONEOUS RESULTS WERE GENERATED AND NO OPERATORS WERE HARMED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE USER INTERFACE TSM COMPUTER WAS BURNED INTERNALLY AND THE EVIDENCE INDICATED SOME SORT OF SPILL OCCURRED ON THE OPEN COOLING DUCTS OF THE COMPUTER. HE NOTED THE POWER SUPPLY WAS DAMAGED. THE FIELD SERVICE REPRESENTATIVE REPLACED THE TSM COMPUTER, INSTALLED THE CURRENT SOFTWARE REVISION AND RESTORED THE BACKUP CONFIGURATION. TO VERIFY THE ANALYZER OPERATION, HE RAN PATIENT SPECIMENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPA AUTOMATED PREANALYTICAL SYSTEM JQP ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1