BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2082830 · Received April 28, 2011

    Report

    Report Number
    3004209178-2011-81247
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 49MG/DL. THE CUSTOMER DELIVERED A BOLUS OF 3.8 UNITS, BUT THE BOLUS HISTORY SHOWED 20 UNITS. THE CUSTOMER STATED THAT HE WAS ASLEEP DURING HIS LAST DELIVERY. THE PARAMEDICS WERE CALLED LATER AND TREATED HIM WITH TWO GLUCAGON SHOTS TO RAISE HIS GLUCOSE LEVEL. THE CUSTOMER STATED THAT HE DO NOT REMEMBER THE GLUCOSE READING AT TIME OF HIS ARRIVAL TO THE MEDICAL FACILITY. THE CUSTOMER ALSO STATED THAT THE DEVICE MAKES A LOUD NOISE UPON REWIND AND THE NUMBERS ON THE SCREEN WERE RAMPING WITHOUT PRESSING ANY BUTTONS. THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. THE AMOUNT OF INSULIN IN THE RESERVOIR MATCHES WITH THE INSULIN ON DISPLAY. THE CUSTOMER STATED THAT HE HAS BEEN DIAGNOSED WITH CANCER AND HAS BEEN RECEIVING CHEMOTHERAPY. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. 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 60 YR Hospitalization