BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3934602 · Received June 27, 2014

    Report

    Report Number
    3007981285-2014-01643
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TROUBLESHOOTING BETWEEN TANDEM TECHNICAL SUPPORT AND THE CUSTOMER, THE CUSTOMIZABLE AUTO OFF FEATURE WAS DISCUSSED AND CUSTOMER WAS SATISFIED WITH INFORMATION PROVIDED. NO PRODUCT RETURNING FOR EVALUATION. ATTEMPTS HAVE BEEN MADE TO OBTAIN ALL EVENT INFORMATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING CUSTOMER'S PUMP ALARMED AND SHUT OFF WHILE CUSTOMER WAS SLEEPING. CUSTOMER DID NOT UNDERSTAND THE MEANING OF THE ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376106 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other