BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2212988 · Received August 8, 2011

    Report

    Report Number
    2032227-2011-01998
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED A BUTTON ERROR ALARM THAT DOES NOT CLEAR DUE TO UNRESPONSIVE BUTTONS. THE CUSTOMER ALSO STATED THAT SHE EXPERIENCED LOW BLOOD GLUCOSE LEVELS AND A SEIZURE WHILE SHE NAPPED, PRIOR TO CALLING. THE CUSTOMER STATED THAT THE PARAMEDICS WERE CALLED, AND SHE WAS TREATED. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS DROPPED FROM 235 TO 50 MG/DL. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    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-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention