BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3920873 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86572
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER'S WIFE THAT HE HAD BEEN INVOLVED IN AN AUTOMOBILE ACCIDENT BUT WAS NOT WEARING HIS INSULIN PUMP, CAUSING HIS BLOOD GLUCOSE LEVEL TO GO LOW. AUTOMOBILE ACCIDENT OCCURRED ON (B)(6) OF 2014. CUSTOMER HAD REPORTED AN ISSUE WITH THE DEVICE EARLIER THAT DAY, WHICH LED TO HIM BEING ADVISED TO DISCONNECT AND RETURN THE INSULIN PUMP FOR ANALYSIS. BLOOD GLUCOSE LEVEL AT TIME OF HOSPITALIZATION WAS BETWEEN 18 TO 20 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398277 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization