BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASANTE COMFORT

    MDR report key: 3599722 · Received December 4, 2013

    Report

    Report Number
    8021545-2013-00013
    Event Type
    Malfunction
    Date Received
    December 4, 2013
    Date of Event
    September 16, 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

    UNOMEDICAL A/S RECEIVED THE COMPLAINT THROUGH (B)(4), THE DISTRIBUTOR OF THE INFUSION SET. THE INTERNAL REFERENCE NUMBER FOR THIS COMPLAINT (B)(4). 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 NO 8021545-11/19/2013-0006. USED DEVICE: A VISUAL INSPECTION AND A TEST FOR FLOW WERE PERFORMED ON THE RETURNED USED DEVICE. IN THE VISUAL INSPECTION, THE TUBING WAS DETACHED FROM THE TUBING-ASANTE CONNECTOR. THE FLOW TEST WAS IN ACCORDANCE WITH SPECIFICATIONS. THE LEAK AND DYNAMIC TESTS OF THE TUBING-ASANTE CONNECTOR CANNOT BE PERFORMED DUE TO THE CONDITION OF THE SAMPLE. UNUSED DEVICES: NO UNUSED DEVICES WERE RETURNED FOR INVESTIGATION. REFERENCE SAMPLES: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND DYNAMIC PULL TUBING-ASANTE CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    "PATIENT PICKED UP PUMP BY THE TUBING AND THE INFUSION TUBING CAME OUT OF THE TUBING CONNECTOR. PATIENT DISPOSED OF THE TUBING CONNECTOR, BUT WILL RMA THE INFUSION TUBING. PATIENT DID NOT REPORT HYPERGLYCEMIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629509 ASANTE COMFORT ASANTE COMFORT FPA UNOMEDICAL A/S 4143-5 0230120

    Patients

    Seq Age Sex Outcome Treatment
    1