BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP MMT-512RNAS

    MDR report key: 1973839 · Received January 20, 2011

    Report

    Report Number
    2032227-2011-00188
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    January 10, 2010
    Report Date
    January 8, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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'S BLOOD GLUCOSE WAS 518 MG/DL AT DINNER TIME. FIFTEEN MINUTES LATER THE CUSTOMER'S GLUCOSE LEVEL STILL WAS READING HIGH ON THE BLOOD GLUCOSE METER. THE CUSTOMER WAS AGITATED. IT WAS STATED THAT THE CUSTOMER HAD A BACK UP PLAN, BUT HE DOES NOT KNOW HOW MUCH INSULIN TO TAKE. VERIFIED AGAIN HIS GLUCOSE LEVEL AND HE REC'D AN ERROR ALARM. THE WIFE TOOK HER HUSBAND TO THE HOSPITAL, AND HE WAS ADMITTED FOR HIGH BLOOD GLUCOSE. THE CUSTOMER'S LAST BLOOD GLUCOSE READING WAS 106 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP MMT-512RNAS INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization