BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2202546 · Received August 5, 2011

    Report

    Report Number
    2032227-2011-01966
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 23, 2011
    Report Date
    July 24, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 750 MG/DL. PRIOR TO THE HOSPITALIZATION, THE CUSTOMER WAS UNABLE TO LOWER HER BLOOD GLUCOSE LEVELS WITH THE INSULIN PUMP. THE CUSTOMER STATED THAT HE HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR THE PAST THREE DAYS, AND SHE FELL IN HER BACK YARD AS WELL. DURING THE CALL, THE CUSTOMER WAS AGAIN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS EVEN THOUGH SHE HAD GIVEN HERSELF SEVERAL UNITS OF INSULIN VIA THE INSULIN PUMP. THE CUSTOMER STATED THAT SHE DID NOT KNOW HOW TO GIVE HERSELF A MANUAL INJECTION, AND REQUESTED EMERGENCY ASSISTANCE. THE PARAMEDICS WERE CALLED FOR THE CUSTOMER, AND SHE WAS TAKEN TO THE HOSPITAL ONCE AGAIN, WITH A BLOOD GLUCOSE READING OF 393 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT FAILED THE HIGH PRESSURE TEST. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization