BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3864547 · Received June 10, 2014

    Report

    Report Number
    2032227-2014-02962
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    December 1, 2013
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. PLEASE SEE MEDWATCH REPORT # 3004209178-2014-85330.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A HOSPITALIZATION IN DECEMBER WHILE CALLING IN TO TROUBLESHOOT A NO DELIVERY ALARM WITH HER INSULIN PUMP AND RESERVOIR. THE CUSTOMER DID NOT RECALL THE EXACT DATE OF HOSPITALIZATION AND DID NOT GIVE FURTHER DETAILS, BUT SAYS SHE WILL CALL BACK WITH MORE INFORMATION. AT THE TIME OF REPORTING, THE PATIENTS BLOOD GLUCOSE WAS AT 180 MG/DL; BLOOD GLUCOSE AT TIME OF HOSPITALIZATION NOT STATED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341431 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization