BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722RNAH PRDGM V2.4 PK EN RC

    MDR report key: 1843461 · Received September 20, 2010

    Report

    Report Number
    2032227-2010-82685
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    August 29, 2010
    Report Date
    August 29, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS DUE TO ISSUES WITH THE INSULIN PUMP. THE REPORTED BLOOD GLUCOSE READING WAS 472 MG/DL. THE CUSTOMER WAS GETTING MULTIPLE NO DELIVERY ALARMS DURING THE MANUAL PRIME PRIOR TO THE EVENT. THE CUSTOMER HAD KETONES, NAUSEA AND FRUITY BREATH WHEN ADMITTED. LATER, THE CUSTOMER'S MOTHER CALL TO TROUBLESHOOT THE INSULIN PUMP. THE INSULIN PUMP PASSED THE PRIME TEST. FOUND THAT THE CUSTOMER WAS GETTING NO DELIVERY ALARMS BECAUSE, SHE WAS USING THE WRONG INFUSION SETS AT THE TIME. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722RNAH PRDGM V2.4 PK EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization