BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAP PRDGM INS V2.1 PL EN

    MDR report key: 1041178 · Received May 13, 2008

    Report

    Report Number
    3004209178-2008-00297
    Event Type
    Injury
    Date Received
    May 13, 2008
    Date of Event
    April 20, 2008
    Report Date
    April 20, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 554 MG/DL. THE CUSTOMER STATED THAT SHE WAS PERSPIRING HEAVILY AND VOMITING. THE CUSTOMER WAS UNABLE TO TROUBLESHOOT DURING THE PHONE CALL AS SHE HAD DISCARDED THE INFUSION SET. THE DIABETIC EDUCATOR LATER CALLED FOR TROUBLESHOOTING. THE INSULIN PUMP WAS DOWNLOADED AND FOUND THAT THE CUSTOMER HAD NOT BEEN BOLUSING. ALSO FOUND THAT THE CUSTOMER CHANGES THE INFUSION SETS EVERY FIVE DAYS. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. THE EDUCATOR STATED THAT HE WILL LET THE DOCTOR AND THE NURSE KNOW THE RESULTS OF THE TESTS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAP PRDGM INS V2.1 PL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization