BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2002572 · Received February 16, 2011

    Report

    Report Number
    3004209178-2011-80445
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    November 25, 2010
    Report Date
    February 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 HUSBAND REPORTED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER'S SPOUSE STATED THAT HIS WIFE EXPERIENCED LOW BLOOD GLUCOSE DUE TO AN OVER INFUSION ON (B)(6) 2010. IT WAS STATED THAT THE CUSTOMER'S GLUCOSE LEVEL WAS LESS THAN 20 MG/DL AND SHE WAS IN A DIABETIC COMA. IT WAS STATED THAT THE PARAMEDICS WERE CALLED AND TOOK HER TO THE EMERGENCY ROOM WHERE SHE STAYED UNDER OBSERVATION, BUT SHE WAS NOT ADMITTED IN THE HOSPITAL. IT WAS STATED THAT THEY BELIEVE THE LOW BLOOD GLUCOSE WAS DUE TO CHEMOTHERAPY AND HER BASALS WERE ADJUSTED DUE THE CHEMOTHERAPY MEDICATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization