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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: T:SLIM X2 INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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T:SLIM X2 INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number 1000354
Medical Device Problem Code Premature Discharge of Battery (1057)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/22/2025
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the pump battery was depleting quickly.There was no reported adverse impact to the customer¿s blood glucose level.The customer declined further troubleshooting with tandem technical support; therefore no additional information could be obtained.
 
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Brand Name
T:SLIM X2 INSULIN PUMP
Common Device Name
PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
Manufacturer Contact
michael trier
12400 high bluff drive
san diego, CA 92130
858 401-1451
MDR Report Key22751663
Report Number3013756811-2025-188321
Device Sequence Number15611795
Product Code OYC
UDI-Device Identifier00853052007981
UDI-Public00853052007981
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P140015
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Health Professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/08/2025
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model Number1000354
Device Catalogue Number1003808
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/30/2025
Initial Report FDA Received Date08/08/2025
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured11/16/2018
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Reuse
Patient Sequence Number1
Patient SexUnknown
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