BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASANTE COMFORT

    MDR report key: 3599739 · Received December 4, 2013

    Report

    Report Number
    8021545-2013-00009
    Event Type
    Malfunction
    Date Received
    December 4, 2013
    Date of Event
    August 14, 2013
    Report Date
    November 29, 2013
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K120872
    Removal / Correction Number
    8021545-11/19/2013-0006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR REPORT HAS BEEN MADE SINCE THIS EVENT HAS LED TO A RECALL. THIS INCIDENT HAS ALREADY BEEN REPORTED TO THE FDA IN THE ASR REPORT FOR Q3 2013. IN NOVEMBER 2013, A VOLUNTARY PRODUCT RECALL FOR THE DEVICE WAS INITIATED AND REPORTED TO THE FDA UNDER REPORT #(B)(4). ACCORDING TO THE EVAL RESULT, WHICH IS AN EXTRACT OF THE INFO SENT TO THE FDA IN RELATION TO THE RECALL. A VISUAL INSPECTION AND A TEST FOR FLOW, LEAK AND STATIC PULL WERE PERFORMED ON THE RETURNED USED DEVICE. THE TUBING WAS DETACHED FROM THE ASANTE CONNECTOR AND FOR THIS CONDITION IT WAS LEAKING. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND STATIC PULL OF TUBING CONNECTOR. THE TUBING WAS DETACHED FROM THE ASANTE RESERVOIR CONNECTOR. NO UNUSED DEVICES WERE RETURNED FOR INVESTIGATION. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND STATIC PULL OF TUBING-CONNECTOR. THE TUBING WAS DETACHED FROM THE ASANTE RESERVOIR CONNECTOR (7 OUT OF 10). UNOMEDICAL A/S RECEIVED THE COMPLAINT THROUGH ASANTE SOLUTIONS, THE DISTRIBUTOR OF THE INFUSION SET. THE INTERNAL REFERENCE NUMBER FOR THIS COMPLAINT AT ASANTE SOLUTION IS (B)(4).

    Description of Event or Problem · 1

    PT HAD THE INFUSION TUBING DETACH FROM THE TUBING CONNECTOR IN THE MIDDLE OF THE NIGHT. HE WOKE UP IN DIABETIC KETOACIDOSIS (DKA) WITH A BLOOD SUGAR TEST OF 420 AND VOMITING. PT SELF-TREATED AND DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629297 ASANTE COMFORT ASANTE COMFORT FPA UNOMEDICAL A/S 4127-5 0230119

    Patients

    Seq Age Sex Outcome Treatment
    1