BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522WWP PRDGM INSULIN PL EN ML

    MDR report key: 1933171 · Received December 14, 2010

    Report

    Report Number
    3004209178-2010-83597
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 11, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE MOTHER REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS NOT DELIVERING INSULIN PROPERLY, AND HER DAUGHTER HAD SEVERAL UNEXPLAINED HIGH BLOOD GLUCOSE. IT WAS ALSO STATED THAT THE DEVICE DID NOT ALARM FOR NO DELIVERY. IT WAS STATED THAT SOMETIMES THE CANNULA COMES WITH ADHESIVE STILL ON IT. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522WWP PRDGM INSULIN PL EN ML INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522WWP

    Patients

    Seq Age Sex Outcome Treatment
    1