BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAB PRDGM INS V2.2 BL EN

    MDR report key: 1041177 · Received May 13, 2008

    Report

    Report Number
    3004209178-2008-00296
    Event Type
    Injury
    Date Received
    May 13, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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. 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

    THE CUSTOMER STATED THAT HE WAS HOSPITALIZED FOR HYPOGLYCEMIA WITH A BLOOD GLUCOSE READING OF 47 MG/DL. THE CUSTOMER STATED THAT THE HOSPITAL HAS TAKEN HIM OFF OF THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE CUSTOMER WAS ADVISED TO SPEAK TO HIS DOCTOR ABOUT OTHER POSSIBLE CAUSES FOR THE LOW BLOOD GLUCOSE LEVELS. EXPLAINED TO THE CUSTOMER THAT THE INSULIN PUMP PASSED THE TESTING AND WAS FUNCTIONING PROPERLY. ADVISED TO MONITOR THE INSULIN PUMP AND THE BLOOD GLUCOSE LEVELS CLOSELY AND CALL BACK IF FURTHER ASSISTANCE IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAB PRDGM INS V2.2 BL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization