BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522WWS PRDGM INSULIN SK EN ML

    MDR report key: 1012644 · Received March 11, 2008

    Report

    Report Number
    3004209178-2008-00168
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 29, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED- REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE CUSTOMER WAS TAKEN TO THE HOSPITAL AFTER EXPERIENCING SEVERAL NO DELIVERY ALARMS. NO BLOOD GLUCOSE READING WAS REPORTED. THE INFUSION SET WAS CHANGED DURING THE HOSPITAL STAY AND THE NO DELIVERY ALARMS DID NOT RETURN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522WWS PRDGM INSULIN SK EN ML INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED- REL MMT-522WWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention