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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 1002717
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 03/29/2022
Event Type  Injury  
Event Description
It was reported that the customer experienced a low blood glucose (bg) level of 51-53 mg/dl resulting in a loss of consciousness. The suspected cause of the low bg was due to pump settings being too high. At the time of the event, no issues were identified with the cartridge, infusion set tubing, infusion set cannula, or insulin. The customer's wife provided assistance by taking the customer to the emergency room (er). While in the er, the customer was treated with glucagon injection and glucose tablets. The treatment resolved the issue and the customer sustained no permanent damage. The customer adjusted the basal and carbohydrate ratio settings on the pump to address the event.
 
Manufacturer Narrative
No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted.
 
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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
mick trier
san diego, CA 92121
8584011451
MDR Report Key14170051
MDR Text Key289771767
Report Number3013756811-2022-37020
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeAU
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 03/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1002717
Device Catalogue Number1007420
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2021
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: 04/21/2022 Patient Sequence Number: 1
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