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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. TANDEM T-SLIM X2; PUMP, INFUSION, INSULIN
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TANDEM DIABETES CARE, INC. TANDEM T-SLIM X2; PUMP, INFUSION, INSULIN Back to Search Results
Model Number 001000354
Device Problem Loss of Data (2903)
Patient Problem Insufficient Information (4580)
Event Date 12/13/2021
Event Type  malfunction  
Event Description
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).
 
Event Description
Additional information received on 01/19/2022 for report: mw5106111.Procode for device number three is qfg.
 
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Brand Name
TANDEM T-SLIM X2
Type of Device
PUMP, INFUSION, INSULIN
Manufacturer (Section D)
TANDEM DIABETES CARE, INC.
MDR Report Key13019768
MDR Text Key282421595
Report NumberMW5106111
Device Sequence Number3
Product Code PHV
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 12/13/2021
6 Devices were Involved in the Event: 1   2   3   4   5   6  
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number001000354
Patient Sequence Number1
Treatment
DEXCOM CGM; TANDEM INSULIN PUMP
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