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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 Hypoglycemia (1912); Seizures (2063)
Event Date 02/19/2019
Event Type  Injury  
Manufacturer Narrative
No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the customer's blood glucose (bg) was low. Customer consumed glucagon and glucose tablets. Customer had a seizure. Contact transported customer to the emergency room (er). Bg was 52 mg/dl upon arrival to er. Customer's bg/ketone levels were measured and customer was instructed to go the healthcare provider's office. Customer's bg was in the low 200 mg/dl range and customer "was doing better". Contact did not know cause of low bg. As tandem technical support (cts) was not contacted at the time of the event, a cause could not be determined.
 
Manufacturer Narrative
Tandem quality engineer evaluated pump data and concluded the following: blood glucose (bg) of 45 mg/dl was entered into the pump by the user on (b)(6)2019 at (b)(6)am. Immediately following, user requested a 25 unit bolus for a bg of 459 mg/dl. The user likely entered the bg of 45 mg/dl in error. Bg values of 45-52 mg/dl were recorded by continuous glucose monitor (cgm) from (b)(6)am. Cgm alert 3 (cgm glucose reading below user threshold) and cgm alert 1 (cgm low alert) were annunciated. Prior to the low bg, user requested a 10. 79 unit bolus for a bg of 251 mg/dl. There were no erratic basal rate adjustments. There were no obvious requests or deliveries that would cause bg levels to drop. There is no evidence that the pump experienced a malfunction or failure.
 
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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 Key8466930
MDR Text Key140432235
Report Number3013756811-2019-16326
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1000096
Device Catalogue Number1000886
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received06/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Treatment Data
Date Received: 03/29/2019 Patient Sequence Number: 1
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