BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2800610 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-90234
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 10, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    THE CUSTOMER REPORTED HAVING LOW BLOOD GLUCOSE OF 16MG/DL AND THE PARAMEDICS WERE CALLED AND TREATED HER WITH GLUCOSE AT THE SCENE. THE CUSTOMER MENTIONED BEING IN A CAR ACCIDENT AND SHE WAS THE DRIVER. THE CALLER STATED THAT THE CAUSE OF HER LOW BLOOD GLUCOSE WAS STRESS. THE CUSTOMER STATED THAT SHE FELT HER BLOOD GLUCOSE WAS LOW, BUT SHE DID NOT PULL OFF THE ROAD BEFORE HAVING THE ACCIDENT. TROUBLESHOOTING WAS DECLINED AS CUSTOMER STATED THAT THE INSULIN PUMP IS FUNCTIONING PROPERLY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization