BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1864742 · Received October 5, 2010

    Report

    Report Number
    3004209178-2010-83038
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 25, 2010
    Report Date
    September 25, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 BD DRAWN AT THIS TIME. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE OF 358MG/DL. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING A BOLUS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE LAST INFUSION SET HAD A BENT CANNULA, AND THE DEVICE DID NOT ALARM. EXPLAINED TO THE CUSTOMER THAT THE ALARM MAY BE CAUSED BY A SITE ISSUE. INSTRUCTED THE CUSTOMER TO CHANGE THE INFUSION SET AND CHOOSE A SITE FREE OF SCAR TISSUE IF POSSIBLE. THE CUSTOMER STATED THAT SHE IS ON HER WAY TO AN URGENT CARE FOR TREATMENT. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization