BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1993490 · Received February 8, 2011

    Report

    Report Number
    3004209178-2011-80369
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    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 EXPERIENCING LOW BLOOD GLUCOSE BECAUSE SHE OVER BOLUS DURING NIGHT AND THE PARAMEDICS WERE CALLED. THE BLOOD GLUCOSE READING WAS 49MG/DL AFTER TAKING SEVERAL GLUCOSE TABLETS AND HAVING SEVERAL CUPS OF FRUIT DRINK. ADVISED THE CUSTOMER THAT SINCE HE IS GOING LOW AND THEN HIGHER, HIS BLOOD GLUCOSE WAS PROBABLY NOT STABLE TO CALIBRATE CAUSING MOST LIKELY ISSUES WITH HIS GLUCOSE LEVEL. 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 MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention