BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 6100234 · Received November 14, 2016

    Report

    Report Number
    3007981285-2016-18698
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 24, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:FLEX PUMP USER GUIDE INDICATES THAT ONLY HUMALOG AND NOVOLOG HAVE BEEN TESTED BY TANDEM DIABETES AND FOUND TO BE COMPATIBLE FOR USE IN THE T:FLEX SYSTEM. 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 ERROR MESSAGES. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 160 TO 228 MG/DL. TANDEM TECHNICAL SUPPORT HAD THE CUSTOMER REVIEW THE PUMP HISTORY AND IT WAS FOUND THAT THE CUSTOMER HAD RECEIVED OCCLUSION ALARMS. AS THE PUMP SUPPLIES HAD BEEN CHANGED PRIOR TO CONTACTING TANDEM CUSTOMER TECHNICAL SUPPORT (CTS), A SYSTEM CHECK WAS UNABLE TO BE PERFORMED TO DETERMINE A POSSIBLE CAUSE OF THE OCCLUSIONS. THERE WAS NO REPORTED DAMAGE TO THE CARTRIDGE OR CANNULAS. REPORTEDLY, THE CUSTOMER HAD BEEN USING APIDRA INSULIN IN THE CARTRIDGE. CTS INFORMED THE CUSTOMER THAT APIDRA WAS NOT LABELED FOR USE IN THE CARTRIDGE. THE CUSTOMER ACKNOWLEDGED THE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751294 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR INSULIN: APIDRA, INFUSION SET: CLEO