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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP

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TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP Back to Search Results
Model Number 1000096
Device Problem Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2023
Event Type  malfunction  
Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a malfunction alarm occurred.During troubleshooting with tandem technical support, the malfunction alarm was cleared, and insulin delivery was resumed successfully.Customer¿s blood glucose level was 274 mg/dl.
 
Manufacturer Narrative
D1, d2b, g4 d1, d2b, g4.
 
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Brand Name
T:SLIM X2 INSULIN PUMP
Type of Device
INSULIN PUMP
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
Manufacturer Contact
michael trier
san diego, CA 92130
8584011451
MDR Report Key16833550
MDR Text Key314407201
Report Number3013756811-2023-55750
Device Sequence Number1
Product Code LZG
UDI-Device Identifier00852162004781
UDI-Public(01)00852162004781
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/05/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1000096
Device Catalogue Number1000103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 04/08/2023
Initial Date FDA Received04/28/2023
Supplement Dates Manufacturer Received03/13/2024
Supplement Dates FDA Received04/05/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age33 YR
Patient SexFemale
Patient EthnicityNon Hispanic
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