BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2870073 · Received December 12, 2012

    Report

    Report Number
    2032227-2012-07993
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    PATIENT

    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, VIA SOCIAL MEDIA, THAT SHE HAS BEEN HAVING SEVERAL ISSUES WITH THE INSULIN PUMP RECENTLY. THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED TWICE DUE TO DIABETIC KETOACIDOSIS, AND WAS SUSPICIOUS THAT HER INSULIN PUMP WAS NOT DELIVERING INSULIN TO HER. THE CUSTOMER STATED THAT SHE LATER FOUND OUT THAT THE NO DELIVERY ALARM WAS NOT FUNCTIONING. THE CUSTOMER ALSO STATED THAT SHE HAS BUILT UP SCAR TISSUE BECAUSE, SHE HAS BEEN USING THE WRONG INFUSION SET FOR HER BODY TYPE ALL THIS TIME. ANOTHER COMPLAINT WAS THAT SHE RECEIVED A LOW BATTERY ALARM, AND HAD TO USE SEVEN DIFFERENT BATTERIES BEFORE ONE WORKED. THE CUSTOMER WAS VERY UPSET WITH THE PRODUCT, AND STATED THAT SHOULD WOULD BE CHANGING COMPANIES. ATTEMPTED TO CONTACT THE CUSTOMER SEVERAL TIMES, BUT THERE WAS NO ANSWER. LEFT SEVERAL MESSAGES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL NOT SPECIFIED INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization