BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAL PRDGM INS V2.2 CL EN

    MDR report key: 1941860 · Received December 22, 2010

    Report

    Report Number
    2032227-2010-83501
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 4, 2010
    Report Date
    December 4, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN FOR ASSISTANCE, BUT DID NOT RESPOND FOR THE FIRST THREE MINUTES. ASKED THE CUSTOMER IF HE WAS OKAY, AND HE FINALLY RESPONDED, SAYING HE WAS OKAY. SHORTLY AFTER, THE PARAMEDICS ARRIVED. THE PARAMEDICS STATED THAT THEY HAD BEEN TO THIS CUSTOMER'S HOME BEFORE, THEN HUNG UP THE PHONE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAL PRDGM INS V2.2 CL EN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention