BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3023960 · Received March 27, 2013

    Report

    Report Number
    2032227-2013-01171
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 16, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH HIGH BLOOD GLUCOSE LEVELS. THE CALLER STATED THAT THE INSULIN PUMP WAS ALARMING NO DELIVERY, AND THE DOCTOR WOULD LIKE FOR SOMEONE TO GO TO THE HOSPITAL TO TROUBLESHOOT. ADVISED THE CALLER THAT TROUBLESHOOTING IS CONDUCTED OVER THE PHONE. THE CALLER DID NOT HAVE THE INSULIN PUMP WITH HER AT THE TIME OF THE CALL, AND STATED SHE WOULD HAVE THE CUSTOMER CALL IN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126679 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization