BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6141993 · Received December 2, 2016

    Report

    Report Number
    3007981285-2016-22988
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 10, 2016
    Report Date
    November 10, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 "004889", SERIAL #- ADDED "(B)(4)"). PMA/510K #- ADDED "K111210." DEVICE MANUFACTURE DATE- ADDED "4/3/2015."

    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 HOSPITALIZED. THE BLOOD GLUCOSE (BG) IMPACT WAS NOT PROVIDED. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER TO COMPLETE TROUBLESHOOTING; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792655 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R