BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2112396 · Received May 26, 2011

    Report

    Report Number
    3004209178-2011-81586
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR A NON-DIABETES-RELATED EVENT. THE CUSTOMER STATED THAT A MOTOR ERROR ALARM OCCURRED AND THAT SHE HAD WORN THE INSULIN PUMP WHEN SHE HAD AN MRI DONE FOR HER BRAIN SURGERY. THE CUSTOMER THEN STATED THAT SHE IS UNABLE TO PERFORM THE DISPLACEMENT TEST AND THAT THE INSULIN PUMP CONTINUES TO GIVE MOTOR ERROR ALARMS DURING EACH REWIND. THE CUSTOMER FURTHER STATED THAT SHE HAS BEEN HAVING HIGH BLOOD GLUCOSE OF 481 MG/DL BUT WAS TREATED AN INTRAVENOUS INSULIN DRIP. NOTHING FURTHER WAS REPORTED.

    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-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization