BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5799364 · Received July 15, 2016

    Report

    Report Number
    3007981285-2016-90913
    Event Type
    Malfunction
    Date Received
    July 15, 2016
    Date of Event
    May 24, 2016
    Report Date
    June 24, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE, INTERMITTENT OCCLUSION ALARMS. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED BETWEEN 200-223 MG/DL. THE CUSTOMER WOULD EITHER DELIVER A CORRECTION BOLUS OR USE INSULIN INJECTIONS TO ADDRESS THE BG LEVEL. AFTER THE LAST OCCLUSION ALARM, A SYSTEM CHECK WAS PERFORMED AND THE INFUSION SET SITE APPEARED TO BE THE CAUSE OF THE OCCLUSION; HOWEVER, AFTER THE SITE WAS CHANGED ANOTHER OCCLUSION OCCURRED. THE CUSTOMER DECLINED TANDEM TECHNICAL SUPPORT'S OFFER TO TROUBLESHOOT TO DETERMINE THE CAUSE OF THE LAST ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452475 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M017976

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR