BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO OPTIMO

    MDR report key: 3801648 · Received May 9, 2014

    Report

    Report Number
    9610824-2014-00035
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 15, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    BK080013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS PERFORMING MAINTENANCE ON TANGO OPTIMO WITH THE FRONT ACRYLIC COVER REMOVED WHEN THE PIPETTOR NEEDLES STARTED MOVING AND THE RINSE CYCLE STARTED. THE COVER HAD BEEN REMOVED BY GOING TO THE MAINTENANCE MENU AND SELECTING REMOVE FRONT COVER. THE TANGO OPTIMO OPERATOR HAS NOT BEEN HURT BY THIS INCIDENT. THE INVESTIGATION OF THIS INCIDENT IS STILL ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS PERFORMING MAINTENANCE ON TANGO OPTIMO WITH THE FRONT ACRYLIC COVER REMOVED WHEN THE PIPETTOR NEEDLES STARTED MOVING AND THE RINSE CYCLE STARTED. THE COVER HAD BEEN REMOVED BY GOING TO THE MAINTENANCE MENU AND SELECTING REMOVE FRONT COVER. THE TANGO OPTIMO OPERATOR HAS NOT BEEN HURT BY THIS INCIDENT. AN INTERNAL CAPA WAS INITIATED AND CLOSED. THE RISK OF A RECURRENCE OF THIS PROBLEM WAS CONSIDERED TO BE VERY LOW. ADDITIONALLY, THE RISK THAT A TANGO OPTIMO USER MIGHT SUFFER AN INJURY FROM THIS INCIDENT WAS ASSESSED TO BE NOT LIKELY AT ALL. THE WORST THAT MAY HAPPEN TO AN USER IS A VERY SLIGHT BLOW OF THE PIPETTOR AGAINST HIS OR HER HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280886 TANGO OPTIMO AUTOMATED BLOOD BANK ANALYSER SYSTEM KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1