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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 Problems Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Visual Impairment (2138)
Event Date 08/01/2019
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned; however, the device has not yet been received. A supplemental report will be submitted if the device is received.
 
Event Description
It was reported that the customer experienced intermittent low and high blood glucose (bg) levels. The customer provided a bg range of 20-450 mg/dl, however, declined to provide the bg value for most recent elevated bg and reported experiencing large ketone levels identified as dangerous. Reportedly, customer treated low bg with glucagon shot and glucose gel. Customer's husband delivered glucose gel and glucagon shot to assist with low bg. Elevated bg was treated with insulin via bolus using the pump and manual injection. The customer alleged that the pump was not delivering the correct amount of basal insulin; however acknowledged that elevated bg levels also occurred due to over correction for low bg. Reportedly, customer sustained "floaters" in the left eye. The customer reverted to manual injections for insulin therapy.
 
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Brand NameT:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
Type of DeviceAUTOMATED 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 Key9088626
MDR Text Key159228006
Report Number3013756811-2019-58601
Device Sequence Number1
Product Code OZO
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
Type of Report Initial,Followup
Report Date 09/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000096
Device Catalogue Number1000886
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received10/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/19/2019 Patient Sequence Number: 1
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