BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2243545 · Received September 2, 2011

    Report

    Report Number
    3004209178-2011-82812
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 EXPERIENCING HIGH BLOOD GLUCOSE FOR THE PAST TWO DAYS, AND THEN THE CUSTOMER WAS HOSPITALIZED. THE CUSTOMER WAS DISCONNECTED FROM THE INSULIN PUMP AND RECEIVED AN INSULIN DRIP. THE CUSTOMER STATED THAT HER DOCTOR RECOMMENDED HAVING THE INSULIN PUMP REPLACED. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 379 MG/DL. THE CUSTOMER RETURNED HOME AND WAS READY TO RESUME THE INSULIN PUMP THERAPY, BUT SHE IS CONCERNED BECAUSE OF THE PREVIOUS HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT SHE BELIEVES THE INSULIN PUMP WAS NOT FUNCTIONING PROPERLY. ADVISED THE CUSTOMER TO CHANGE THE INFUSION SET AND RESERVOIR AND CALL US BACK IF ISSUES RECURRED. NO FURTHER INFO WAS PROVIDED.

    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 CO., JUNCOS MMT-522NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization