BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2902229 · Received January 8, 2013

    Report

    Report Number
    2032227-2013-00053
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 15, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 900 MG/DL. PRIOR TO THE HOSPITALIZATION, THE CUSTOMER REMOVED THE INSULIN PUMP TO TREAT WITH MANUAL INJECTIONS, BUT HE STATED THAT HE WASN'T ABLE TO KEEP HIS BLOOD GLUCOSE LEVELS DOWN. THE CUSTOMER STATED THAT HE IS STILL IN THE HOSPITAL, AND THE INSULIN PUMP HAS BEEN MISPLACED. THE CUSTOMER REQUESTED A REPLACEMENT INSULIN PUMP AS SOON AS POSSIBLE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9182 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization