BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515LNAP PRDGM INS V2.1 PL EN

    MDR report key: 1912615 · Received November 23, 2010

    Report

    Report Number
    2032227-2010-83256
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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 DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE. IT WAS STATED THAT THE INSULIN PUMP DID NOT DELIVER ANY INSULIN AND THE INFUSION SETS WERE CHANGED THREE TIMES, BUT THE NO DELIVERY ALARM CONTINUED. THE CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM AND TREATED WITH 16 UNITS OF NOVOLOG AND 4.5 UNITS OF LANTUS. THE MOTHER STATED THAT SHE TRIED TO DISCONNECT AND RAN A BOLUS, BUT IT CONTINUED TO ALARM NO DELIVERY. THE MOTHER ALSO STATED THAT THE DEVICE WAS SQUIRING THE INSULIN OUT DURING MANUAL PRIME. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515LNAP PRDGM INS V2.1 PL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization