BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3182738 · Received June 21, 2013

    Report

    Report Number
    2032227-2013-02512
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    CUSTOMER REPORTED HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. CUSTOMER'S CURRENT BLOOD GLUCOSE READING WAS 478 MG/DL. CUSTOMER IS THIRSTY. CUSTOMER TREATED WITH MANUAL INJECTION. PARAMEDICS WERE CALLED TO TREAT BLOOD GLUCOSE READING OF 40 MG/DL. CUSTOMER ALSO HAD A WOUND ON THE LEG. CUSTOMER ALSO STATED THAT THE BLOOD GLUCOSE LEVEL WENT TO 14 AND A HEART ATTACK OCCURRED. ADVISED CUSTOMER THAT THE INSULIN PUMP WILL BE REPLACED, DUE TO COSMETIC DAMAGE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283878 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization