BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6110806 · Received November 17, 2016

    Report

    Report Number
    3007981285-2016-19912
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 28, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM PUMP USER GUIDE INDICATES THAT THE CARTRIDGE IS CONTRAINDICATED FOR USE WITH PRODUCTS OTHER THAN HUMALOG AND NOVOLOG. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE, INTERMITTENT OCCLUSION ALARMS. AFTER THE MOST RECENT OCCLUSION, THE CUSTOMER CHANGED THE PUMP SUPPLIES AND ANOTHER OCCLUSION WAS RECEIVED. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 250 MG/DL AND AN INSULIN INJECTION WAS USED TO ADDRESS THE BG LEVEL. THE CUSTOMER CHANGED THE SUPPLIES AGAIN AND INSULIN DELIVERY WAS RESUMED, THE CUSTOMER STATED THAT SINCE USING APIDRA INSULIN, OCCLUSIONS HAVE OCCURRED. TANDEM TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT APIDRA WAS NOT LABELED FOR USE WITH THE PUMP. THE CUSTOMER ACKNOWLEDGED THE INFORMATION AND WAS GOING TO LOOK INTO SWITCHING THE TYPE OF INSULIN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761465 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other INSULIN: APIDRA