BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3727482 · Received February 24, 2014

    Report

    Report Number
    3007981285-2014-00195
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 27, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Removal / Correction Number
    Z-0827-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT# M001454.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING PATIENT HAD EXPERIENCED HIGH AND LOW BG'S. IT IS UNKNOWN WHICH LOT NUMBER WAS BEING USED AT THE TIME OF EVENT. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113130 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628 M001344

    Patients

    Seq Age Sex Outcome Treatment
    1