BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2101561 · Received May 20, 2011

    Report

    Report Number
    3004209178-2011-81543
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    May 11, 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
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED FOR HYPERGLYCEMIA, WITH A BLOOD GLUCOSE OF 847 MG/DL. THE CUSTOMER STATED THAT THREE DAYS PRIOR TO THE EVENT, SHE HAD EXPERIENCED LOW BLOOD GLUCOSE LEVELS BECAUSE THE INSULIN PUMP DELIVERED MOST OF THE REMAINING 20 UNITS OF INSULIN OVER NIGHT. FURTHERMORE, THE CUSTOMER STATED THAT ABOUT A WEEK BEFORE THE EVENT, SHE HAD BRIEFLY BEEN IN A ROOM WHILE SOMEONE WAS HAVING AN MRI DONE. THE CUSTOMER ALSO STATED THAT SHE LAST CHANGED HER INFUSION SET THREE DAYS BEFORE THE EVENT AND THAT SHE USES A SILHOUETTE INFUSION SET. PROGRAMMING WAS CORRECT. 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-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization UNOMEDICAL SILHOUETTE INSULIN INFUSION SET:| MODEL: MMT-378