BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4123514 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29638
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    CUSTOMER CALLED IN TO REPORT THE INSULIN PUMP ALARMED MOTOR ERROR DURING PRIME. CUSTOMER DID NOT KNOW BLOOD GLUCOSE LEVEL. CUSTOMER DOES NOT RECALL ANY PREVIOUS SIGNIFICANT EVENT THAT MAY HAVE CAUSED THE DEVICE TO ALARM. THE DEVICE WAS NOT EXPOSED TO MRI. ALARM WAS CLEARED. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE. CUSTOMER DOES NOT USE THE SENSOR FEATURE. CUSTOMER WAS UNABLE TO REWIND THE DEVICE. CUSTOMER'S BOYFRIEND CALL BACK AND STATED THE DEVICE ALARMED MOTOR ERROR AGAIN AND CUSTOMER HAD WOKEN UP WITH BLOOD GLUCOSE OF 488 MG/DL, TREATED WITH BACK UP PLAN. CUSTOMER HAD TO COMPLETE DONATION PROCESS. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602290 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR