BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2101557 · Received May 20, 2011

    Report

    Report Number
    3004209178-2011-81539
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. MEDWATCH 2 OF 2 (RESERVOIR): 3004209178-2011-81542.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GOING TO THE HOSPITAL BECAUSE HE WAS WORRIED THE INSULIN PUMP WAS NOT FUNCTIONING CORRECTLY. THE CUSTOMER STATED THAT HE HAD REC'D EXCESSIVE NO DELIVERY ALARMS OVER THE PAST COUPLE OF DAYS AND THAT THE NO DELIVERY ALARMS OCCURRED DURING BASALS. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE FIXED PRIME AND THE HIGH PRESSURE TESTS. 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-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization