BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYS

    MDR report key: 3812748 · Received May 5, 2014

    Report

    Report Number
    3007981285-2014-00535
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 9, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 HAD MULTIPLE OCCLUSIONS DUE TO KINKED CANNULAS; HOWEVER, THE PUMP DID NOT ALARM. REPORTEDLY, THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS ELEVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268015 TANDEM T:SLIM INSULIN DELIVERY SYS INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR INFUSION SET: UNK