BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4223139 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-47456
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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. 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 EXPERIENCED A HIGH BLOOD GLUCOSE LEVEL OF 714 MG/DL. THE CUSTOMER WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2014 BECAUSE OF HER HIGH BLOOD GLUCOSE LEVEL AND SHE WAS NOT WEARING THE INSULIN PUMP AT THAT TIME OF HOSPITALIZATION. THE CUSTOMER ALSO REPORTED THAT SHE DID NOT TRUST HER INSULIN PUMP BECAUSE IT NEVER INFORMED HER WHEN THE INSULIN WAS LOW. AT THE HOSPITAL SHE WAS GIVEN INSULIN DRIP FIRST AND THEN MANUAL INSULIN INJECTIONS TO TREAT HER HIGH BLOOD GLUCOSE LEVEL. THE PRODUCT WAS NOT RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705238 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| O