BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522RNAB PRDGM INS BL EN RC

    MDR report key: 1840877 · Received September 17, 2010

    Report

    Report Number
    2032227-2010-82670
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 28, 2010
    Report Date
    August 28, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 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

    THE CUSTOMER STATED THAT HE PUT THE RESERVOIR IN THE INSULIN PUMP WHILE HE WAS CONNECTED, AND RECEIVED A LARGE AMOUNT OF INSULIN. THE PARAMEDICS WERE CALLED FOR ASSISTANCE AS THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE QUICKLY DROPPING. MADE A FOLLOW UP PHONE CALL TO THE CUSTOMER, AND FOUND THAT HE WAS TAKEN TO THE HOSPITAL. HIS BLOOD GLUCOSE LEVELS WENT AS LOW AS 66 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522RNAB PRDGM INS BL EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization