BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712WWL PRDGM INSULIN CL EN

    MDR report key: 1932882 · Received December 14, 2010

    Report

    Report Number
    3004209178-2010-83589
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 3, 2010
    Report Date
    December 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HYPOGLYCEMIA. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE CUSTOMER RECEIVED EXCESSIVE INSULIN WHEN BOLUSING. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712WWL PRDGM INSULIN CL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-712WWL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization