BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2944817 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-90837
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 25, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 21MG/DL. THE CUSTOMER BELIEVES THAT SHE OVER BOLUSED WHILE CHANGING THE INFUSION SET. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE PROGRAMMING AND FOUND THAT THE BASAL RATES HAVE BEEN ADJUSTED SINCE THE EVENT. THE CALLER STATED THAT THE DEVICE WAS NOT EXPOSED TO HIGH MAGNETIC FIELD. THE CUSTOMER STATED THAT THE DOCTOR RECOMMENDED HAVING THE DEVICE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47850 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization