BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2111816 · Received May 26, 2011

    Report

    Report Number
    3004209178-2011-81615
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 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
    AZ, 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 THAT SHE WAS HOSPITALIZED FOR HYPOGLYCEMIA, WITH BLOOD GLUCOSE OF 22 MG/DL. THE CUSTOMER STATED THAT SHE HAD RECEIVED A COUPLE OF LOW BLOOD GLUCOSE ALARMS PRIOR TO THE EVENT, BUT HAD SLEPT AND WAS UNCERTAIN IF SHE HAD CLEARED THE ALARMS. IT WAS FOUND IN THE BOLUS HISTORY THAT 25 UNITS OF INSULIN HAD BEEN DELIVERED OVER NIGHT FOLLOWED BY TWO LOW RESERVOIR ALARMS. THE CUSTOMER ALSO STATED THAT SHE HAD CHANGED HER SENSOR THE DAY BEFORE THE EVENT. PROGRAMMING WAS CORRECT. NOTHING FURTHER WAS REPORTED.

    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-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization