BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9397342 · Received December 2, 2019

    Report

    Report Number
    3013756811-2019-88456
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    August 31, 2019
    Report Date
    December 2, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007325
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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 MULTIPLE OCCLUSION ALARMS OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE AND THAT A CARTRIDGE ALARM OCCURRED AFTER OVERFILLING THE CARTRIDGE. CUSTOMER ALSO REPORTED HAIRLINE CRACKS IN MULTIPLE CARTRIDGES. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 250-481 MG/DL. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER ON THE REPORTED ISSUE; HOWEVER, NO RESPONSE FROM THE CUSTOMER WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189773 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007325

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR INSULIN: NOVOLOG/NOVORAPID