BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722NAH PRDGM INS PK

    MDR report key: 1853785 · Received October 1, 2010

    Report

    Report Number
    3004209178-2010-82980
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 19, 2010
    Report Date
    September 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    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 UNK 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS RUNNING HIGH, AND THE INSULIN PUMP DID NOT ALARM NO DELIVERY. THE BLOOD GLUCOSE AT TIME OF THE CALL WAS 518MG/DL. THE MOTHER STATED THAT THE INFUSION SET, RESERVOIR, INSULIN, AND SITE WERE CHANGED, THE MOTHER ALSO STATED THAT SHE RAN A BOLUS WITHOUT CUSTOMER CONNECTED AND NOTHING DRIPS OUT OF THE TUBING. ADVISED THE MOTHER TO SEEK MEDICAL ATTENTION AS THE CUSTOMER HAS TESTED POSITIVE FOR KETONES. TROUBLESHOOTING WAS PERFORMED. THE MOTHER REQUESTED A REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAH PRDGM INS PK INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR