BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3874022 · Received June 5, 2014

    Report

    Report Number
    3007981285-2014-01001
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVALUATION. ATTEMPTS WERE MADE TO OBTAIN ALL AVAILABLE INFORMATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING CUSTOMER IS EXPERIENCING EXPECTED HIGH BLOOD GLUCOSE LEVELS FOLLOWING CARTRIDGE CHANGES. THE CUSTOMER ALSO REPORTS RECEIVING MULTIPLE OCCLUSION ALARMS DURING BOLUS AND BASAL DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE NOT IMPACTED BY THE OCCLUSION ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329432 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R