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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2, BASAL-IQ, MMOL/L AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

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TANDEM DIABETES CARE T:SLIM X2, BASAL-IQ, MMOL/L AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND Back to Search Results
Model Number 1002717
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 02/27/2021
Event Type  Injury  
Manufacturer Narrative
Device not returned.
 
Event Description
It was reported that the customer's blood glucose (bg) was 19 mg/dl and customer lost consciousness. An ambulance transported customer to the emergency unit. Customer was treated with a glucagon injection and "intravenous sugar". Customer regained consciousness. Customer was discharged the next day and insulin therapy was resumed. Customer did not know cause of low bg. Pump history showed a sensor expiring and high bg alerts had occurred prior to event. Customer had all basal-iq reminders set to "on". Customer could not recall further details of the event.
 
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Brand NameT:SLIM X2, BASAL-IQ, MMOL/L
Type of DeviceAUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
Manufacturer Contact
mick trier
san diego, CA 92121
8584011451
MDR Report Key11563540
MDR Text Key242057645
Report Number3013756811-2021-33106
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K201214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1002717
Device Catalogue Number1002684-D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received03/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2020
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: 03/24/2021 Patient Sequence Number: 1
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