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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

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TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND Back to Search Results
Model Number 1000096
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Hypoglycemia (1912)
Event Date 07/26/2019
Event Type  Injury  
Event Description
It was reported that the customer experienced a low blood glucose (bg) (no value provided); cause was unknown.Reportedly, the customer fell down stairs due to low bg.Glucose tablets were consumed to treat bg level.Recommendation was made to consult with healthcare provider regarding diabetes management.Reportedly the customer continued to use the pump for insulin therapy.The customer also had manual injection supplies available.
 
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Brand Name
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
Type of Device
AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
Manufacturer Contact
julia kensick
11075 roselle st.
san diego, CA 92121
8583666900
MDR Report Key8951910
MDR Text Key156165823
Report Number3013756811-2019-53215
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00853052007264
UDI-Public00853052007264
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P180008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number1000096
Device Catalogue Number1000886
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2019
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 08/09/2019
Initial Date FDA Received08/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age20 YR
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