BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4773976 · Received May 15, 2015

    Report

    Report Number
    3004209178-2015-56709
    Event Type
    Injury
    Date Received
    May 15, 2015
    Date of Event
    April 25, 2015
    Report Date
    April 25, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HE HAD A LOW BLOOD GLUCOSE EARLIER TODAY. CUSTOMER ATE SOMETHING AND EXERCISED. CUSTOMER STATED THAT HIS BLOOD GLUCOSE WAS LOW AGAIN. CUSTOMER STATED THAT HE NEVER PUT THE PUMP ON SUSPEND. CUSTOMER CHECKED HIS BLOOD GLUCOSE AND IT IS NOW 400 MG/DL. CUSTOMER STATED THAT THE PUMP IS LOCKED AND NOT DELIVERING INSULIN. CUSTOMER HAD A LOCKED SCREEN AND WAS ABLE TO UNLOCK IT. CUSTOMER STATED THAT THE PUMP WAS RUNNING AS IT NORMALLY RUNS. CUSTOMER STATED THAT HE MAY HAVE BEEN ON THE WRONG SCREEN WHEN HE TRIED TO UNSUSPEND THE PUMP. CUSTOMER WAS ABLE TO BOLUS AND TREAT HIS BLOOD GLUCOSE. CUSTOMER STATED THAT HIS BLOOD GLUCOSE WAS COMING DOWN. CUSTOMER STATED THAT HE WILL MONITOR HIS BLOOD GLUCOSE AND CALL BACK IF HE NOTICES ANY RECURRING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319914 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR