BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4121133 · Received September 24, 2014

    Report

    Report Number
    3007981285-2014-07804
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP SAME DAY INDICATED THAT NO FURTHER OCCLUSION ALARMS HAD OCCURRED. BLOOD GLUCOSE LEVEL WAS REPORTED AS "GOOD." 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 CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED (141 MG/DL - 171 MG/DL). CUSTOMER INITIATED A MANUAL CORRECTION BOLUS. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE INFUSION SET CANNULA WAS FOUND TO BE KINKED. THE CUSTOMER REPLACED THE CANNULA/SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594704 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE, INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other INSULIN: NOVOLOG| INFUSION SET: QUICKSET