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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 Hypoglycemia (1912); Nerve Damage (1979); Loss of consciousness (2418)
Date of Event 07/17/2021
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 went to the emergency room and was subsequently hospitalized due to a low blood glucose (bg) level of 12 mg/dl.Cause of low bg was unknown.Customer was treated with sugar water and intravenous fluids of saline and insulin.Reportedly, low bg resulted in unconsciousness and nerve damage in customer's foot.Customer was released from the hospital 15 days later.
 
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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 Key12516148
Report Number3013756811-2021-103703
Device Sequence Number12008541
Product Code LZG
UDI-Device Identifier00852162004378
UDI-Public(01)00852162004378
Combination Product (Y/N)N
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 company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/22/2021
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
Device Lot NumberM939907
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 09/01/2021
Initial Report FDA Received Date09/22/2021
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 Hospitalization; Required Intervention;
Patient Age42 YR
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