BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4193053 · Received October 21, 2014

    Report

    Report Number
    3007981285-2014-10011
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 24, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER; HOWEVER, NO RESPONSE WAS RECEIVED FORM THE CUSTOMER. NO ADDITIONAL OCCLUSION ALARMS HAVE BEEN REPORTED. THE PRODUCT HAS NOT BEEN 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 OCCLUSION ALARMS. REPORTEDLY, THE INSULIN APPEARED TO BE GELLED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, IT WAS RECOMMENDED THAT ALL SUPPLIES, INCLUDING INSULIN BE CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669644 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M003314

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other INSULIN: HUMALOG