BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4162510 · Received July 16, 2014

    Report

    Report Number
    3007981285-2014-03308
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    T:SLIM USER GUIDE INDICATES "IF YOU ARE GOING HAVE AN X-RAY, COMPUTERIZED TOMOGRAPHY (CAT) SCAN, MAGNETIC RESONANCE IMAGING (MRI), OR OTHER EXPOSURE TO RADIATION, TAKE OFF YOUR T:SLIM PUMP AND REMOVE IT FROM THE PROCEDURE ROOM". NO PRODUCT RETURNING FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION REGARDING A CARTRIDGE ALARM 19 DURING THE BASAL DELIVERY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416256 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M003088

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR