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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); Vomiting (2144); Loss of consciousness (2418)
Event Date 03/06/2021
Event Type  Injury  
Manufacturer Narrative
Device not returned.
 
Event Description
It was reported that the customer's blood glucose (bg) was a bit low (value not provided); cause was not known. At the time of the event, the customer did not have a continuous glucose monitoring session on, as such the customer¿s parents were not aware that the customer¿s bg level was very low. Parent provided customer with dextrose. Bg elevated to 196 mg/dl. Parent delivered a correction bolus via pump (pump history showed 0. 96 units of insulin delivered) and 30 minutes later customer experienced a seizure due to "very low bg". Parent provided dextrose and soda. Customer "woke up after 2 minutes". Bg was 84 mg/dl. Customer vomited and refused to eat. Ambulance transported customer to the hospital. Customer was treated with intravenous glucose and was discharged the same day. Upon follow up, family was "doing ok". No pump issues were identified.
 
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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 Key11590356
MDR Text Key242977743
Report Number3013756811-2021-33221
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeSE
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 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1002717
Device Catalogue Number1004223-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 Received03/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2020
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: 03/30/2021 Patient Sequence Number: 1
Treatment
INSULIN: NOVORAPID
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