BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4102048 · Received September 15, 2014

    Report

    Report Number
    3007981285-2014-07024
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 17, 2014
    Report Date
    August 17, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. IN ADDITIONAL, T:SLIM USER GUIDE INDICATES PUMP IS TO BE USED WITH INDIVIDUALS 12 YEARS AND GREATER; PATIENT IS (B)(6).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THAT CUSTOMER RECEIVED A LOW FILL ESTIMATE AFTER COMPLETING THE LOAD PROCESS; SHE FILLED THEIR CARTRIDGE WITH 125 UNITS, YET THE FILL ESTIMATE WAS ONLY 65 UNITS. CUSTOMER USED COLD INSULIN. REPORTEDLY, THERE WAS NO IMPACT TO THE USER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569075 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M004205

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR