BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

    MDR report key: 5799216 · Received July 15, 2016

    Report

    Report Number
    2432235-2016-00368
    Event Type
    Malfunction
    Date Received
    July 15, 2016
    Date of Event
    June 24, 2016
    Report Date
    August 18, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. CONTINUES TO INVESTIGATE HOW THE CUSTOMER WAS INJURED WHILE PERFORMING THE CENTERING COLLAR MAINTENANCE PROCEDURE ON THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT. IT IS UNKNOWN WHAT THE INJURY WAS AND WHAT TREATMENT, IF ANY, THE CUSTOMER RECEIVED AT THEIR OCCUPATIONAL HEALTH DEPARTMENT.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) FILED THE INITIAL MDR (2432235-2016-00368) ON JULY 15, 2016. AUGUST 1, 2016, ADDITIONAL INFORMATION: SIEMENS' INVESTIGATION CONFIRMED THAT THE CUSTOMER INJURED HERSELF WHILE REPLACING THE CENTERING COLLAR ON THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT. THE INJURY OCCURRED AT A POINT IN THE CENTERING COLLAR MAINTENANCE PROCEDURE WHERE THE RED NEEDLE GUARD COULD NOT BE USED. THE AUTOSAMPLER NEEDLE PIERCED THE CUSTOMER'S SKIN AND SHE WAS BLEEDING FROM THE INJURY. THE CUSTOMER WENT TO THEIR OCCUPATIONAL HEALTH DEPARTMENT AND IS FOLLOWING TREATMENT TO PREVENT (B)(6) INFECTION. SIEMENS HAS DETERMINED THAT THE CAUSE OF THE CUSTOMER'S INJURY ON THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT IS OPERATOR'S TECHNIQUE WHEN PERFORMING THE CENTERING COLLAR MAINTENANCE ON THE INSTRUMENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER INJURED THEMSELVES WHILE PERFORMING THE CENTERING COLLAR MAINTENANCE PROCEDURE ON THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT. THE CUSTOMER MET WITH THE HOSPITAL'S OCCUPATIONAL HEALTHCARE PROFESSIONAL BUT IT IS UNKNOWN WHAT THE INJURY WAS AND WHAT SORT OF TREATMENT, IF ANY, WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER INJURING THEMSELVES WHILE PERFORMING THE CENTERING COLLAR MAINTENANCE PROCEDURE ON THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453205 ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR