BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 4190487 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41062
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE TRANSMITTER WAS RECEIVED WITH CONTAMINATION ON CONTACT PINS. HOWEVER, THE TRANSMITTER PASSED FUNCTIONAL TESTING.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HAVING TROUBLE WITH HER MINILINK AND TESTER. CUSTOMER STATED THAT SHE CLEANED HER TRANSMITTER AND WOULD NOT GO IN AND FELL OFF INTO THE SINK AND GOT WET. CUSTOMER STATED HAD WATER INSIDE THE HOLE. ADVISED CUSTOMER THE TRANSMITTER WOULD BE REPLACED. CUSTOMER'S BLOOD GLUCOSE WAS 153 MG/DL. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666942 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR