BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3930691 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03700
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 62 MG/DL. THE CUSTOMER STATED SHE WAS CONCERNED THAT THE BOLUS WIZARD WAS GIVING HER MORE INSULIN THAN SHE NEEDED. SHE TREATED WITH GLUCOSE TABLETS. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND INSPECT THE DRIVE SUPPORT CAP. CUSTOMER STATED THE DRIVE SUPPORT CAP APPEARED NORMAL. SHE STATED THAT HER PUMP THERAPIST HAD INCREASED THE BASAL RATES. CUSTOMER LOWERED THE BASAL RATES BACK DOWN. THE INSULIN PUMP SETTINGS WERE CORRECT. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP ALARMED FOR A MOTOR ERROR. SHE STATED THAT THE ALARM OCCURS RANDOMLY AND DURING SET CHANGES. SHE STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD AND SHE WAS ABLE TO CLEAR THE ALARM AND PERFORM A REWIND. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408910 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR