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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 Problem Hyperglycemia (1905)
Event Date 06/04/2022
Event Type  Injury  
Event Description
It was reported that the customer went to the emergency room (er) due to a blood glucose (bg) level ranging from 360-397 mg/dl. A manual insulin injection was administered and the infusion set was changed to address bg level prior to arriving at the er. Reportedly, the customer did not receive any treatment at the er, and subsequently, the customer was released from the er a "few hours" later. The cause for the reported issue was unknown, however, the customer suspected the infusion set to potentially be the cause for the issue. The customer declined performing a system check with tandem technical support.
 
Manufacturer Narrative
Device not returned.
 
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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 Key14843434
MDR Text Key294910489
Report Number3013756811-2022-67480
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeCA
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 06/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1002717
Device Catalogue Number1002684
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received06/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2019
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: 06/28/2022 Patient Sequence Number: 1
Treatment
INFUSION SET: AUTOSOFT 90, INSULIN: ADMELOG
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