BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSLIM INSULIN PUMP

    MDR report key: 17560482 · Received August 15, 2023

    Report

    Report Number
    MW5144625
    Event Type
    Injury
    Date Received
    August 15, 2023
    Date of Event
    May 10, 2023
    Report Date
    August 11, 2023
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    PQF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE HAD 3 T-SIM INSULIN PUMPS. ALL THREE HAVE FAILED LEAVING ME WITH DIABETES KETOACIDOSIS. I HAVE NOT DROPPED SPILLED ON OR OTHERWISE DAMAGED THE DEVICES. I WAS HOSPITALIZED AFTER A RIDE IN AN AMBULANCE THREE TIMES. I WAS IN ICU TWO TIMES. IT TOOK ALMOST A WEEK TO GET MY ELECTROLYTES AND OTHER BLOOD VALUES CORRECTED. I HAVE CHOSEN NOT TO USE THE NEW PUMP THEY SENT ME BECAUSE I DON'T TRUST THEM ANYMORE. AM I THE ONLY PATIENT HAVING THIS PROBLEM? MY NAME IS (B)(6), (B)(6), MN (B)(6). EMAIL IS (B)(6) AND MY TELEPHONE IS (B)(6). I HAVE TYPE 1 DIABETES. MY DOCTOR IS (B)(6), M.D. IN THE HOSPITAL I HAD NUMEROUS BLOOD TESTS AND BLOOD SUGAR TESTS. REFERENCE REPORTS: MW5144624, MW5144626.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994729 TSLIM INSULIN PUMP SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE PQF TANDEM DIABETES CARE, INC. WO766174

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization| O BUPROPION 200 MG BID.| CIMETIDINE 800MG ONCE/DAY.| CLONAZEPAM 0.5 MG AS NEEDED.| EMERGENCY INHALER.| GLUCOSE TABLETS.| INSULIN AND LANTUS.| KIRKLAND ALLER-FLO NASAL SPRAY. | MIGHTY REDS VITAMINS.| N: NOVELOG PENS.| OMEPRAZOLE DR 40 MG ONCE PER DAY.| SERTRALINE 100 MG BID.| SIMVASTATIN 40 MG ONCE PER DAY.| TEMAZEPAM 15MG AS NEEDED.