BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAB PRDGM INS BL EN ML

    MDR report key: 1873075 · Received October 15, 2010

    Report

    Report Number
    2032227-2010-82939
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 26, 2010
    Report Date
    September 29, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS WITH A BLOOD GLUCOSE READING OVER 605 MG/DL. THE CUSTOMER'S MOTHER STATED THAT PRIOR TO THE EVENT, THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS HIGH ALL DAY AND SHE WAS VOMITING. THE CUSTOMER'S MOTHER ALSO STATED THAT SHE THOUGHT THE CUSTOMER WAS GETTING INFLUENZA. THE CUSTOMER'S MOTHER THEN STATED THAT THE DOCTOR AT THE HOSPITAL REMOVED THE SET AND FOUND A BENT CANNULA. THE CUSTOMER CALLED LATER AND REPORTED THAT AFTER RETURNING HOME FROM THE HOSPITAL, SHE WAS TREATED BY PARAMEDICS FOR LOW BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER FOUND THAT THE INSULIN PUMP GAVE 57 UNITS IN A TWO HOUR PERIOD. THE DAILY TOTALS DID NOT INDICATE THAT 57 UNITS WERE DELIVERED. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAB PRDGM INS BL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention