BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3073649 · Received April 23, 2013

    Report

    Report Number
    2032227-2013-01498
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED WITH CONCERNS THAT THE INSULIN PUMP MIGHT NOT BE WORKING CORRECTLY. THE CUSTOMER STATED THAT HIS DAUGHTER HAD TO CALL THE PARAMEDICS AFTER HE BLACKED OUT AND FELL ON SOME CHAIRS. THE CUSTOMER'S BLOOD GLUCOSE WAS 41 MG/DL. THE CUSTOMER STATED THAT HE HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS EVERY MORNING FOR THE PAST THREE DAYS, AND HAS HAD TO REMOVE THE INSULIN PUMP AT 3:00 AM TO AVOID ANOTHER INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE METER IS NOT COMMUNICATING WITH THE INSULIN PUMP. TROUBLESHOOTING REVEALED THAT THE METER OPTION WAS TURNED OFF. ASSISTED IN TURNING THE FEATURE ON, AND IT SUCCESSFULLY TRANSFERRED OVER THE BLOOD GLUCOSE READING. THE CUSTOMER STATED THAT HE WOULD BE SPEAKING WITH HIS HCP ABOUT HIS CURRENT SETTINGS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175136 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention