BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3950457 · Received July 3, 2014

    Report

    Report Number
    3007981285-2014-02039
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVAL. SHOULD NEW INFO BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THE T:SLIM USER GUIDE INDICATES THAT THE CARTRIDGE IS CONTRAINDICATED FOR USE WITH PRODUCT OTHER THAN HUMALOG AND NOVOLOG.

    Description of Event or Problem · 1

    RECEIVED INFO STATING THAT CUSTOMER USES APIDRA AND HAS HAD MULTIPLE OCCLUSION ALARMS. SHE'S NOW OFF THE PUMP AND IS CURRENTLY ON PENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391105 TANDEM:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening| O INSULIN ASPIDRA| INFUSION SET INSET