BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3004040 · Received January 30, 2009

    Report

    Report Number
    3004209178-2009-17748
    Event Type
    Injury
    Date Received
    January 30, 2009
    Date of Event
    January 13, 2009
    Report Date
    January 13, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    OYC
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAW AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE WAS TREATED BY PARAMEDICS DUE TO HYPOGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 40 MG/DL. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE INSULIN PUMP WAS PROGRAMMED AND READING THE RESERVOIR VOLUME CORRECTLY. THE CUSTOMER LAST CHANGED THE INFUSION SET TWO DAYS PRIOR TO THE EVENT AND WAS PRACTICING THE CORRECT PRIMING TECHNIQUE. AFTER THE INITIAL PHONE CALL, IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA AGAIN AND WAS SUBSEQUENTLY HOSPITALIZED. NOTHING FURTHER WAS REPORTED.

    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 62 YR Hospitalization