BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3912834 · Received June 13, 2014

    Report

    Report Number
    3007981285-2014-01133
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. AS PER CUSTOMER, NO FURTHER ASSISTANCE IS REQUIRED. SHOULD NEW INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING PATIENT EXPERIENCING HIGH BG'S (433 MG/DL) AND STOPPED USING T:SLIM INSULIN PUMP AND WENT BACK TO PREVIOUS INSULIN PUMP. DURING TROUBLESHOOTING PATIENT OBSERVED AIR BUBBLES AT LUER LOCK AND FOUND THAT HE DID NOT RESUME INSULIN AFTER PUMP ALERTED HIM TO RESULTING IN REPORT OF HIGH BG'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349731 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention