BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAB PRDGM INS BL EN ML

    MDR report key: 1951859 · Received December 28, 2010

    Report

    Report Number
    2032227-2010-83576
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 13, 2010
    Report Date
    December 14, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT HER INSULIN PUMP HAD A BLANK DISPLAY TWICE DAYS BEFORE. THE CUSTOMER ALSO STATED THAT THE DEVICE HAD A BATTERY ALARM, BUT THE DATA WAS INTACT. TROUBLESHOOTING WAS PERFORMED. THE BASALS, BOLUS, AND DAILY TOTALS WERE CORRECT. THE CUSTOMER STATED THAT SHE HAS BEEN USING A VERY SMALL AREA IN THE BACKSIDE TO INSERT HER INFUSION SET FOR OVER TWO YRS. THE CUSTOMER STATED THAT SHE HAD MANY HIGH AND LOW BLOOD GLUCOSE. SUGGESTED THE CUSTOMER TO HAVE A GOOD ROTATION AND TO USE OTHER AREAS FOR HER SITES. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAB PRDGM INS BL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization