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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM INSULIN DELIVERY SYSTEM; INSULIN PUMP
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TANDEM DIABETES CARE T:SLIM INSULIN DELIVERY SYSTEM; INSULIN PUMP Back to Search Results
Model Number 004628
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event 06/30/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported that the customer required assistance to treat a low blood glucose level and an elevated blood glucose level (value not provided).No additional information was provided.Multiple contact attempts were made by tandem technical support to obtain additional information regarding the event; however, no response was received from the customer.
 
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Brand Name
T:SLIM INSULIN DELIVERY SYSTEM
Common Device Name
INSULIN PUMP
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
MDR Report Key12345329
Report Number3013756811-2021-92155
Device Sequence Number3794783
Product Code LZG
UDI-Device Identifier00852162004378
UDI-Public(01)00852162004378
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
K111210
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Y
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Model Number004628
Device Catalogue Number007444
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/30/2021
Initial Report FDA Received Date08/19/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age30 YR
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