BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB

    MDR report key: 1962770 · Received January 11, 2011

    Report

    Report Number
    3004209178-2011-80126
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    January 4, 2010
    Report Date
    January 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    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'S INSULIN PUMP ALARMED MOTOR ERROR DURING A BOLUS. TROUBLESHOOTING WAS PERFORMED. RAN A SELF TEST AND DISPLACEMENT AND THE DEVICE PASSED THE TEST. PERFORMED A MANUAL PRIME AND THE DEVICE DID NOT ALARM. INSTRUCTED THE MOTHER OF CHANGE THE ENTIRE INFUSION SET AND TO CHECK THE CUSTOMER'S GLUCOSE LEVEL. THE MOTHER STATED THAT HIS BLOOD GLUCOSE READS 600MG/DL. THE MOTHER ALSO STATED THAT SHE CALLED TO THE DOCTOR AND SHE WOULD BE TAKING THE CUSTOMER TO THE HOSPITAL. NO FURTHER INFO WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization