BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6197839 · Received December 22, 2016

    Report

    Report Number
    3007981285-2016-27361
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    October 1, 2016
    Report Date
    December 12, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCHSCREEN IS INTERMITTENTLY UNREADABLE. REPORTEDLY, AT TIMES WHEN THE TOUCHSCREEN WAS ILLUMINATED THE PIXELS WOULD NOT APPEAR NORMAL. CUSTOMER STATED THE SCREEN WOULD HAVE TO TURN OFF AND THEN BACK ON TO APPEAR NORMAL. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER ON THE REPORTED ISSUE. NO RESPONSE FROM THE CUSTOMER WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851185 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR