BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3790166 · Received May 5, 2014

    Report

    Report Number
    2032227-2014-02228
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS RECEIVED IN WITH LOUD MOTOR NOISE DURING REWIND DUE TO A FAULTY MOTOR. THE DEVICE PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TESTS. ALL OPERATED CURRENTS WERE NORMAL AND NO BATTERY OUT LIMIT ALARM OBSERVED DURING ANALYSIS. A CRACKED RESERVOIR TUBE LIP, SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW, STAINED END CAP STICKER AND CRACKED BATTERY TUBE THREADS NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE HAD UNEXPLAINED HIGH BLOOD GLUCOSE AND DKA. CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM AND WAS HOSPITALIZED. THE BLOOD GLUCOSE READING WAS OVER 700 MG/DL. CUSTOMER STATED THAT HIS INFUSION SET CANNULA WAS BENT, NOTICED WHEN IT WAS REMOVED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267601 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization