BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722RNAL PRDGM INS CL EN RC

    MDR report key: 1060341 · Received June 13, 2008

    Report

    Report Number
    2032227-2008-00979
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 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

    IT WAS REPORTED THAT THE CUSTOMER DID NOT COMPLETE THE PRIMING PROCESS ON THE INSULIN PUMP CORRECTLY, CAUSING 15.8 UNITS OF INSULIN TO BE DELIVERED INTO HER BODY. IT WAS ADVISED THAT THE CUSTOMER SEEK EMERGENCY MEDICAL TREATMENT TO AVOID A HYPOGLYCEMIC EVENT. A FOLLOW-UP CALL WAS ATTEMPTED, BUT WAS UNSUCCESSFUL IN REACHING THE CUSTOMER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722RNAL PRDGM INS CL EN RC INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization