BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3023986 · Received March 27, 2013

    Report

    Report Number
    2032227-2013-01175
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH MOTOR ERROR ALARM DURING REWIND. ERROR ALARM CONFIRMED IN HISTORY FILE DUE TO CORRODED MOTOR HOME SWITCH. UNABLE TO PERFORM DISPLACEMENT TEST, BASIC OCCLUSION, OCCLUSION AND NO DELIVERY TESTS DUE TO MOTOR ERROR ALARM.

    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 REPORTED A MOTOR ERROR ALARM DURING NORMAL USE. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP WENT THROUGH AN AIRPORT BODY SCANNER. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. THE CUSTOMER ALSO REPORTED THAT SHE WAS EXPERIENCING A LOW BLOOD GLUCOSE OF 48 MG/DL. THE CUSTOMER HAD TREATED WITH JUICE, FOOD AND CANDY. THE CUSTOMER HANDED THE PHONE TO HER HUSBAND, AND HE STATED THAT THE CUSTOMER WAS NOT FEELING WELL. HE STATED THAT HE WOULD BE CALLING THE PARAMEDICS FOR ASSISTANCE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126714 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization