BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1931072 · Received December 7, 2010

    Report

    Report Number
    3004209178-2010-83539
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 27, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS ADMITTED IN THE INTENSIVE CARE UNIT FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 1198MG/DL. TROUBLESHOOTING WAS PERFORMED. THE TIME AND DATE WERE CORRECT. IT WAS STATED THAT THE CUSTOMER WAS UNDER MEDICATION FROM HIS DOCTOR AND HIS BASALS WERE EXCHANGED PER HIS DOCTOR'S INSTRUCTIONS. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST TWICE AND THE INSULIN PUMP DID NOT ALARM. ADVISED THE NURSE TO STOP USE OF THE INSULIN PUMP AND TO REVERT TO BACK UP PLAN. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAS PRDGM INS V2.2 SK EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization