BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 2893398 · Received November 5, 2007

    Report

    Report Number
    3004209178-2007-04702
    Event Type
    Injury
    Date Received
    November 5, 2007
    Date of Event
    October 15, 2007
    Report Date
    October 15, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS ADMITTED TO THE HOSPITAL DUE TO LOW BLOOD GLUCOSE AND THE READING WAS 65 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMING WAS CORRECT. THE DISPLACEMENT TEST WAS NOT PERFORMED. THE MOTHER STATED THAT THE BOLUS HISTORY ON THE INSULIN PUMP DID NOT APPEAR TO BE ACCURATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization