BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4999601 · Received August 13, 2015

    Report

    Report Number
    2032227-2015-29180
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 22, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP ALARM MOTOR ERROR DURING PRIME. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN MG/DL. THE CUSTOMER DOESN'T RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. CUSTOMER DIDN'T RECEIVED AN E70 ALARM. THE CUSTOMER STATED THAT THE DEVICE WAS NOT EXPOSED TO MRI OR STRONG MAGNETIC FIELD. THE CUSTOMER WAS ADVISED TO DISCONNECT THE INSULIN PUMP. THE CUSTOMER INSULIN PUMP IS OOW, WE WILL SEND OOW LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535160 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWL

    Patients

    Seq Age Sex Outcome Treatment
    1