BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS AMPLIPREP INSTRUMENT

    MDR report key: 1604169 · Received February 18, 2010

    Report

    Report Number
    2243471-2010-00006
    Date Received
    February 18, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 12, 2010
    Manufacturer
    ROCHE DIAGNOSTICS LTD.
    Product Code
    JJH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVALUATION OF THE COBAS AMPLIPREP INSTRUMENT WAS PERFORMED AS THIS EVENT WAS DUE TO AN INADVERTENT COBAS AMPLIPREP REAGENT TIP NEEDLE STICK. THERE WAS NO REPORT BY THE CUSTOMER THAT THIS ISSUE WAS DUE TO A MALFUNCTION AND/OR A DESIGN LIMITATION OF THE COBAS AMPLIPREP INSTRUMENT. METHOD: A REVIEW OF THE CUSTOMER REPORTED EVENT WAS PERFORMED. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, NO ADDITIONAL EVALUATION WAS PERFORMED. THE COBAS AMPLIPREP INSTRUMENT REAGENT TIP IS UTILIZED TO PIPETTE TEST REAGENTS ONLY; NO POTENTIALLY INFECTIOUS MATERIALS ARE PIPETTED BY THE COBAS AMPLIPREP REAGENT TIP (E.G., PATIENT SPECIMENS).

    Description of Event or Problem · 1

    A TECHNOLOGIST PUNCTURED (THROUGH HER GLOVES) THE PALM OF HER HAND WHILE SHE WAS PERFORMING DAILY MAINTAINANCE OF THE COBAS AMPLIPREP REAGENT TIP. SPECIFICALLY, THE TECHNOLOGIST WAS WIPING THE COBAS AMPLIPREP REAGENT TIP TO CLEAN IT PRIOR TO USE. THE CUSTOMER INDICATED THAT THE TECHNOLOGIST RECEIVED MEDICAL TREATMENT AND MEDICINE (SPECIFIC MEDICAL TREATMENT AND MEDICINE WERE NOT REPORTED). THE CUSTOMER ALSO INDICATED THAT THE TECHNOLOGIST WAS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS AMPLIPREP INSTRUMENT CLINICAL SAMPLE CONCENTRATOR; CFR 862.2310 JJH ROCHE DIAGNOSTICS LTD. 393478

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention