BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIDEPOOL SOFTWARE

    MDR report key: 13019768 · Received December 15, 2021

    Report

    Report Number
    MW5106111
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    December 13, 2021
    Report Date
    December 13, 2021
    Manufacturer
    TIDEPOOL PROJECT
    Product Code
    QFG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 01/19/2022 FOR REPORT: MW5106111. PROCODE FOR DEVICE NUMBER THREE IS QFG.

    Description of Event or Problem · 0

    OUR CLINIC USES (B)(6) TO DOWNLOAD INSULIN, CGM, AND GLUCOMETER DATA. MY SON HAS A TANDEM PUMP. ON TWO SEPARATE OCCASIONS, INCLUDING TODAY, THE (B)(6) SOFTWARE HAS DELETED ALL TREATMENT DATA (BOLUSES, BASAL DOSES, ETC) FROM THE PUMP WHILE I WAS ATTEMPTING TO UPLOAD THE DATA TO THE SYSTEM FOR HIS ENDOCRINOLOGIST TO REVIEW DURING AN EMERGENT MEDICAL ISSUE. THE DATA ARE UNRECOVERABLE. WHEN THIS HAPPENS, THE ENDOCRINOLOGIST CANNOT DETERMINE WHAT TREATMENT ADJUSTMENTS TO MAKE BECAUSE THERE ARE NO DATA AVAILABLE TO REVIEW. (B)(6). I CONTACTED (B)(6), WHO INFORMED ME THAT THEIR SYSTEM IS UNABLE TO WRITE OR DELETE DATA. I CONTACTED TANDEM, AND WAS TOLD THAT BECAUSE IT IS NOT AFFECTING CURRENT INSULIN DELIVERY, IT ISN'T AN ISSUE. WE ARE HAVING SERIOUS ISSUES WITH BLOOD SUGAR CONTROL/INSULIN RESISTANCE/KETONES/ HIGH A1C LEVELS AND THE INSULIN DELIVERY DATA ARE ESSENTIAL FOR MODIFYING HIS TREATMENT PLAN. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913198 TIDEPOOL SOFTWARE CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE QFG TIDEPOOL PROJECT
    1913199 TIDEPOOL SOFTWARE CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE QFG TIDEPOOL PROJECT
    1913200 TANDEM T-SLIM X2 ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE, INC. 001000354
    1913207 TIDEPOOL SOFTWARE CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE QFG TIDEPOOL PROJECT
    1913208 TIDEPOOL SOFTWARE CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE QFG TIDEPOOL PROJECT
    1913209 TANDEM T-SLIM X2 ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE, INC. 001000354

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DEXCOM CGM| TANDEM INSULIN PUMP