BEUDAMED
    FDA Adverse Event Death Summary report: N

    AC TENDER II

    MDR report key: 1032725 · Received April 7, 2008

    Report

    Report Number
    8021545-2008-00001
    Event Type
    Death
    Date Received
    April 7, 2008
    Date of Event
    November 5, 2007
    Report Date
    April 4, 2008
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FOZ
    PMA / PMN Number
    K972135
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNOMEDICAL A/S PERFORMED A VISUAL INSPECTION OF THE RETURNED DEVICE. NO ANOMALIES WERE OBSERVED. FURTHER MORE, A FLOW TEST WAS PERFORMED TO INVESTIGATE IF THE FLOW OF INSULIN WAS OBSTRUCTED. THE DEVICE PASSED THE FLOW TEST. A TEST FOR LEAKAGE WAS THEN PERFORMED AND NO LEAKS WERE DETECTED. SINCE THE LOT NUMBER COULD NOT BE OBTAINED, UNOMEDICAL A/S HAS BEEN UNABLE TO PERFORM ANY TESTING ON THE RETAINED SAMPLES. ALSO, IT WAS NOT POSSIBLY TO CARRY OUT A REVIEW OF THE COMPLAINT FILES OR THE DEVICE HISTORY RECORDS TO SEE IF ANY RELEVANT COMPLAINTS WERE RECEIVED OR IF ANY RELEVANT DEVIATIONS OCCURRED DURING MANUFACTURING OF THE DEVICE. BASED ON THE INFORMATION ABOVE, UNOMEDICAL A/S HAS CONCLUDED THAT THE DEVICE DID NOT CONTRIBUTE TO THE ADVERSE EVENT AND NO CORRECTIVE ACTIONS WILL BE CARRIED OUT. IN RELATION TO THE LATE SUBMISSION OF THE REPORT, UNOMEDICAL WAS INFORMED THAT THE EVENT TOOK PLACE IN ANOTHER COUNTRY. THEREFORE, THE EVENT WAS INITIALLY GOING TO BE REPORTED TO THE FDA THROUGH THE SUBMISSION OF UNOMEDICAL'S QUARTERLY ASR. ON APRIL 3RD 2008 IT WAS BROUGHT TO OUR ATTENTION THAT THE EVENT IN FACT TOOK PLACE IN ANOTHER COUNTRY. WE HAVE ADDRESSED THE ISSUE WITH OUR DISTRIBUTOR TO AVOID SIMILAR MISTAKES IN THE FUTURE.

    Description of Event or Problem · 1

    IN 2007, A HOSPITAL REPRESENTATIVE REPORTED THAT THE PATIENT WAS FOUND UNCONSCIOUS IN HIS HOME. THE PATIENT WAS TAKEN TO HOSPITAL, WHERE THEY REMAINED UNCONSCIOUS. PATIENT WAS PLACED ON INSULIN DRIP, BUT THE PATIENT EXPIRED ON THE NEXT DAY. THE PATIENT LIVED ALONE, SO NO INFORMATION REGARDING THE INCIDENT WERE AVAILABLE FROM THE RELATIVES. THE PATIENT WAS DIAGNOSED WITH HYPOGLYCEMIA AND HYPOXIA. HOSPITAL STAFF REPORTED THAT IT WAS "UNKNOWN IF THE PUMP MALFUNCTIONED OR WAS INAPPROPRIATELY PROGRAMMED BY THE PATIENT." REPEATED ATTEMPTS TO GATHER FURTHER INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC TENDER II COMFORT FOZ UNOMEDICAL A/S NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death INSULIN| UNKNOWN MANUFACTURER| ACCU-CHECK SPIRIT PUMP