BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090157 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81363
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE OF 29MG/DL. IT WAS STATED THAT THE INSULIN PUMP WAS NOT FUNCTIONING PROPERLY, AND ALARMED BUTTON ERROR. THE CUSTOMER WAS NOT ABLE TO CLEAR THE ALARM. THE CUSTOMER REMOVED THE BATTERY AND STARTED ON MANUAL INJECTIONS. IT WAS STATED THAT THE CUSTOMER HAD DINNER AND GAVE HERSELF A MANUAL INJECTION. THE MOTHER STATED THAT THE NEXT DAY HER DAUGHTER WAS UNRESPONSIVE AND SHE WAS TAKEN TO THE HOSPITAL. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING LOW BLOOD GLUCOSE FOR THE PAST DAY. TROUBLESHOOTING WAS PERFORMED. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFO WAS PROVIDED.

    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-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization