BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3834447 · Received May 6, 2014

    Report

    Report Number
    3007981285-2014-00510
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 8, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS RETURNING FOR EVAL; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A FOLLOW UP MDR WILL BE FILED. USE OF APIDRA INSULIN IS CONTRAINDICATED FOR THE T:SLIM CARTRIDGE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270147 TANDEM T:SLIM INSULIN DELIVERY SYSTEM UNSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other INSULIN: APIDRA