BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAB PRDGM INSULIN BLUE EN

    MDR report key: 1853363 · Received October 1, 2010

    Report

    Report Number
    3004209178-2010-82965
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 16, 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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS, AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 176MG/DL. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE INSULIN PUMP ALARMED AND THE CUSTOMER SAW AN EMPTY RESERVOIR. THE CUSTOMER THEN COLLAPSED AND SHE WAS TAKEN TO THE HOSPITAL. THE TIME, DATE, AND BASALS ON THE INSULIN PUMP WERE CORRECT. RAN A DISPLACEMENT TEST AND THE DEVICE PASSED THE TEST. IT WAS STATED THAT 26 UNITS WERE NOT REGISTERED IN THE BOLUS HISTORY, BUT THEY WERE REGISTERED IN THE DAILY TOTALS THE CUSTOMER REQUESTED A REPLACEMENT OF THE INSULIN PUMP. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723NAB PRDGM INSULIN BLUE EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization