BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2853548 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-91007
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. THE PARAMEDICS WERE CALLED TO THE HOUSE, AND THEY GAVE HER A GLUCAGON INJECTION. THE BLOOD GLUCOSE READING WAS 1.6MMOL/L WHEN THE HUSBAND FOUND HER BREATHING HEAVILY IN THE MIDDLE OF THE NIGHT. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER MENTIONED HAVING A BAD COLD FOR THE PAST WEEK. IT WAS STATED THAT INSULIN DID EXIT DURING PRIME, AND THE CUSTOMER CHANGES THE INFUSION SET EVERY THREE DAYS. THE PROGRAMMING, TIME, DATE, AND SETTINGS WERE CORRECT. REVIEWED THE BOLUS HISTORY AND FOUND THAT THE CUSTOMER GAVE HERSELF 24.0 UNITS OF INSULIN, BUT SHE DID REALIZE THAT SHE DELIVERED TWICE 12.0 WITHIN A SHORT PERIOD OF TIME. IT WAS STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. THE CUSTOMER STATED THAT SHE HAS BEEN USING THE INSULIN PUMP AGAIN, AND SHE FELT SAFE WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522WWB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R