BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8649875 · Received May 29, 2019

    Report

    Report Number
    3013756811-2019-28256
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    May 5, 2019
    Report Date
    May 29, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TANDEM QUALITY ENGINEER EVALUATED PUMP DATA AND CONCLUDED THE FOLLOWING: BLOOD GLUCOSE (BG) VALUES OF 40 MG/DL WERE RECORDED BY CONTINUOUS GLUCOSE MONITOR (CGM) FROM 4:14-4:29 AM ON (B)(6)2019. CGM ALERT 3 (CGM GLUCOSE READING BELOW USER THRESHOLD) AND CGM ALERT 1 (CGM LOW ALERT) WERE ANNUNCIATED. AT 11:22 PM ON (B)(6)2019, USER REQUESTED A 1.18 UNIT BOLUS FOR A BG OF 330 MG/DL WHILE STILL HAVING INSULIN ON BOARD (IOB). USER SET SEVERAL TEMPORARY RATES RANGING FROM 50-70% OF BASAL INSULIN ON (B)(6)2019 AND ON (B)(6)2019. MAKING BOLUS REQUESTS WHILE STILL HAVING IOB COULD LEAD TO A LOW BG EVENT. IT IS POSSIBLE THE USER¿S PERSONAL PROFILE SETTINGS NEED ADJUSTMENT. THERE IS NO EVIDENCE THAT THE PUMP EXPERIENCED A MALFUNCTION OR FAILURE.

    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 CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL OF 40 MG/DL; CAUSE WAS UNKNOWN. JUICE AND YOGURT WAS CONSUMED TO TREAT BG LEVEL. RECOMMENDATION WAS MADE TO CONSULT WITH HEALTHCARE PROVIDER REGARDING DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443177 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other