BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3100628 · Received May 8, 2013

    Report

    Report Number
    2032227-2013-01738
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    January 26, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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 STATED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE OF 250 MG/DL. THE CUSTOMER STATED SHE HAD A SINUS INFECTION, AND WAS TREATED WITH ANTIBIOTICS AND STEROIDS. THE CUSTOMER'S BLOOD GLUCOSE LEVELS ELEVATED, AND TREATED WITH AN INJECTION, BUT THAT DID NOT HELP, AND SHE DECIDED TO GO TO THE HOSPITAL. THE CUSTOMER EXPERIENCED SHORTNESS OF BREATH, HEART PALPITATIONS AND NAUSEA. THE CUSTOMER ALSO REPORTED BUTTON ERROR AND FAILED BATTERY TEST ALARMS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE WAS NOT PRESSING ANY BUTTONS FOR MORE THAN THREE MINUTES. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201806 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization