BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6107433 · Received November 16, 2016

    Report

    Report Number
    3007981285-2016-20117
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 26, 2016
    Report Date
    October 27, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION- BRAND NAME- ADDED "TANDEM T:SLIM INSULIN DELIVERY SYSTEM". COMMON DEVICE NAME- CORRECTED TO "INSULIN PUMP". PROCODE- CORRECTED TO "LZG". MODEL #- ADDED "004628", CATALOG #- ADDED "007435", (B)(4). PMA/510K #- ADDED "K111210". DEVICE MANUFACTURE DATE- ADDED "7/28/2016".

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THEIR PUMP; HOWEVER, THE SPECIFIC ISSUES WERE NOT PROVIDED. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758471 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR