BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIO

    MDR report key: 4528418 · Received February 11, 2015

    Report

    Report Number
    3003442380-2015-00004
    Event Type
    Injury
    Date Received
    February 11, 2015
    Date of Event
    October 30, 2014
    Report Date
    February 10, 2015
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K051264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLAIMED FAILURE CAN NOT BE CONFIRMED. THE COMPLAINT HAS BEEN REVIEWED BASED ON THE CUSTOMER COMPLAINT DESCRIPTION AND EVALUATES THAT NO FURTHER INVESTIGATION CAN BE PERFORMED BEFORE EITHER USED SAMPLES ARE RECEIVED FOR TESTING OR THAT THE LOT NUMBER IS PROVIDED TO INVESTIGATE A POTENTIAL ORIGIN OF THE PRODUCT FAILURE IN THE DEVICES MFG TRACEABILITY DOCUMENTS. UNOMEDICAL A/S HEREBY CONSIDER THIS CASE TO BE CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2015 CUSTOMER STATED THAT BACK IN END OF (B)(6) 2014 HAD SOME SIDE PAIN AND WENT INTO ER (NOT RELATED TO DIABETES), WAS TREATED FOR BLADDER AND RELEASED SAME DAY. NEXT MORNING ON THE (B)(6) CUSTOMER COULDN'T WAKE UP. CUSTOMER'S HUSBAND CALLED AMBULANCE AND CUSTOMER WAS TAKING IN TO (B)(6), NE WITH HBGS BETWEEN 800 AND 900 MG/DL. CUSTOMER WAS IN HOSPITAL FOR 2 WEEKS AND COULDN'T WAKE UP, 2 MORE TIMES WHILE IN THERE. CUSTOMER WAS WEARING PUMP BUT THERE WAS NO "NO DELIVERY ALERT". LATER WAS DETERMINED CANNULA WAS BENT. CUSTOMER ALSO MENTIONED BENT CANNULA ON THE (B)(6) HER BG WAS AT 320 MG/DL THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100444 MIO MIO FPA UNOMEDICAL A/S MMT-975 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization