BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522LNAS PRDGM INS SK EN ML

    MDR report key: 1811029 · Received August 10, 2010

    Report

    Report Number
    2032227-2010-82223
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 14, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED BY THE CUSTOMER'S ATTORNEY'S OFFICE: ATTORNEY AND CUSTOMER ALLEGES THAT AN UNK RED LIQUID INAPPROPRIATELY DRIPPED OUT OF THE INFUSION SET TUBING PRIOR TO PRIMING. AND SUSPECTED THAT THE SUBSTANCE ENTERED HIS BODY THROUGH THE INFUSION SET. CUSTOMER CLAIMS POTENTIAL CONTAMINATION BY UNK SUBSTANCE AND FEAR OF INJURY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAS PRDGM INS SK EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR