BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2033756 · Received March 17, 2011

    Report

    Report Number
    3004209178-2011-80700
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 3, 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.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS OF 32 MG/DL. CUSTOMER STATED THAT PRIOR TO THE EVENT, HE WAS ATTENDING A BASKETBALL GAME, AND THAT HE WOKE UP IN THE HOSPITAL. THE CUSTOMER ALSO STATED THAT HE HAS HAD LOW BLOOD GLUCOSE BEFORE. THE CUSTOMER FURTHER STATED THAT HE USES AN MMT-399 QUICK-SET INFUSION SET BUT THE ORIGINAL RESERVOIR AND TUBING HAVE BEEN DISCARDED. 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 57 YR Hospitalization UNOMEDICAL PARADIGM QUICK-SET INFUSION SET,| 23", 6MM