BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522RNAL PRDGM INS CL EN RC

    MDR report key: 1002509 · Received February 26, 2008

    Report

    Report Number
    2032227-2008-00390
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 INITIALLY CALLED TO REPORT NO DELIVERY ALARMS. THE CUSTOMER THEN BEGAN SHOWING SIGNS OF HYPOGLYCEMIA AS SHE BECAME UNRESPONSIVE AND DIFFICULT TO UNDERSTAND. THE PARAMEDICS WERE CALLED AND THE CUSTOMER WAS TAKEN TO THE HOSPITAL. TROUBLESHOOTING REVEALED THAT THE CUSTOMER WAS CONNECTED TO THE INFUSION SET WHEN SHE PERFORMED THE MANUAL PRIME, RESULTING IN THE LOW BLOOD GLUCOSE EVENT. ADVISED THE CUSTOMER ON THE IMPORTANCE OF BEING DISCONNECTED WHILE PERFORMING THE MANUAL PRIME. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522RNAL PRDGM INS CL EN RC INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization