BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 1800

    MDR report key: 1940935 · Received December 17, 2010

    Report

    Report Number
    2432235-2010-00192
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JGS
    PMA / PMN Number
    K990346
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN ORDER TO REPLENISH THE SYSTEM CUVETTE WASH, OPERATORS NEED TO CAREFULLY POUR REAGENT FROM A 2000ML BOTTLE TO THE SYSTEM ON BOARD BOTTLE. PER SIEMENS PRODUCT LABELING, THE CHEMISTRY SERVICE AND OPERATORS GUIDE DESCRIBES THE NECESSARY WARNINGS AND CAUTIONS THAT THE CUSTOMER NEEDS TO FOLLOW BEFORE HANDLING REAGENTS: "READ AND FOLLOW THE CAUTIONS ON THE BOX AND LABEL BEFORE HANDLING ANY REAGENTS. SOME METHOD AND SYSTEM REAGENTS ARE CLASSIFIED AS HAZARDOUS MATERIAL. AVOID CONTACT OF METHOD OR SYSTEM REAGENTS WITH SKIN AND EYES. THESE MATERIALS CAN CAUSE INFECTION AND BURNS. WEAR SUITABLE PROTECTIVE CLOTHING, GLOVES, AND EYE/FACE PROTECTION. IN CASE OF CONTACT WITH EYES, RINSE IMMEDIATELY WITH PLENTY OF WATER AND SEEK MEDICAL ADVICE. IN CASE OF CONTACT WITH SKIN, IMMEDIATELY WASH WITH SOAP AND WATER." THE OPERATOR WAS APPARENTLY NOT WEARING THE PROPER EYE/FACE PROTECTION CAUSING EYE IRRITATION AND BLISTERING. THE OPERATOR DID FLUSH EYE WITH COPIOUS AMOUNTS OF EMERGENCY EYE WASH. THE CUSTOMER APPARENTLY ANNOUNCED AT A TEAM BRIEFING THAT PEOPLE ARE TO WEAR GOGGLES WHEN TOPPING UP BULK REAGENTS ON THE ADVIA 1800 SYSTEM FROM THAT POINT FORWARD.

    Description of Event or Problem · 1

    A SYSTEM OPERATOR WAS SPLASHED IN THE EYE WITH CUVETTE WASH (CONTAINS 3.6% SODIUM HYDROXIDE) WHILE REPLENISHING THE ANCILLARY REAGENTS ON AN ADVIA 1800 SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1800 CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC ADVIA 1800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1