BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3915591 · Received June 4, 2014

    Report

    Report Number
    3007981285-2014-00943
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVAL. HOWEVER, DEVICE EVAL IS NOT YET COMPLETE. A FOLLOW UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    RECEIVED INFO REGARDING A CARTRIDGE ALARM 1. REPORTEDLY, THERE WAS A CRACK ON THE CARTRIDGE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NO IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325851 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628 M002983

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR