BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASANTE COMFORT

    MDR report key: 4224322 · Received October 27, 2014

    Report

    Report Number
    8021545-2014-00019
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 18, 2014
    Report Date
    October 24, 2014
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K120872
    Removal / Correction Number
    8021545-11/19/2013-0006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR HAS BEEN MADE SINCE A SIMILAR EVENT HAS LET TO A RECALL. THIS EVENT WAS WRONGLY NOT REPORTED TO THE FDA IN A TIMELY MANNER. IN NOVEMBER 2013, A VOLUNTARY PRODUCT RECALL FOR THE DEVICE WAS INITIATED AND REPORTED TO THE FDA UNDER REPORT. ACCORDING TO THE EVALUATION, RESULT CODE 100 WHICH IS AN EXTRACT OF THE INFORMATION SENT TO THE FDA IN RELATION TO THE RECALL. USED DEVICE: NO USED DEVICES WERE RETURNED FOR INVESTIGATION. REFERENCE SAMPLES: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND STATIC PULL OF TUBING-ASANTE CONNECTOR. THE TUBING WAS DETACHED FROM THE ASANTE CONNECTOR (5 SAMPLES). THE FLOW AND LEAK TESTS WERE FOUND WITHIN SPECIFICATIONS. UNOMEDICAL A/S RECEIVED THE COMPLAINT THROUGH ASANTE SOLUTIONS, THE DISTRIBUTOR OF THE INFUSION SET. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CONTACTED ASANTE: "HOWEVER, I HAVE HAD SOME ISSUES WITH THE PLASTIC TUBING STAYING ATTACHED TO THE PART THAT SCREWS INTO THE INSULIN CARTRIDGE. TWICE NOW, THEY HAVE DISCONNECTED. I AM PLANNING ON CONTACTING DISTRIBUTOR WITH THE MODEL AND LOT NUMBERS AND OTHER INFORMATION THEY WILL NEED. I DID THINK ASANTE WOULD WANT TO BE KEPT APPRISED OF THAT SITUATION THOUGH. IT IS NOT REAL HANDY HAVING TO CHANGE OUT EVERYTHING AT WORK." ASANTE HAD FOLLOW-UP CONVERSATION WITH CUSTOMER. CUSTOMER STATED THAT THIS HAS HAPPENED WITH 2 DIFFERENT INFUSION SETS SO FAR. SHOULD IT OCCUR ANYMORE, CUSTOMER WILL HAVE SECOND THOUGHTS ABOUT USING SNAP. CUSTOMER DID STATE THAT THE EXPIRATION DATE ON THE INFUSION SETS WAS OCTOBER 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681123 ASANTE COMFORT ASANTE COMFORT FPA UNOMEDICAL A/S 4147-5 5051468

    Patients

    Seq Age Sex Outcome Treatment
    1