BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3893962 · Received June 12, 2014

    Report

    Report Number
    3007981285-2014-01116
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVAL. ATTEMPTS HAVE BEEN MADE TO OBTAIN ALL EVENT INFO. SHOULD NEW INFO BECOME AVAILABLE, A F/U MDR WILL BE SUBMITTED. USE OF APIDRA INSULIN IS CONTRAINDICATED FOR THE T:SLIM CARTRIDGE.

    Description of Event or Problem · 1

    RECEIVED INFO STATING CUSTOMER RECEIVED MULTIPLE OCCLUSION ALARMS DURING BOLUS DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED. REPORTEDLY, THE CUSTOMER IS USING APIDRA INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348695 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other APIDRA