BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2142379 · Received June 21, 2011

    Report

    Report Number
    2032227-2011-01524
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP GAVE A LOW BATTERY ALARM DURING A BOLUS ATTEMPT. THE BATTERY WAS CHANGED, THEN THE INSULIN PUMP ALARMED BUTTON ERROR. THE ALARM COULD NOT BE CLEARED. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 406 MG/DL, AND THE MOTHER STATED THAT SHE WOULD BE TAKING THE CUSTOMER TO THE HEALTH CARE PROFESSIONAL FOR TREATMENT. ADVISED THE MOTHER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization