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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number 1002717
Device Problems Failure to Power Up (1476); Charging Problem (2892)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/06/2022
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received and evaluation is performed.
 
Event Description
It was reported that the pump won't turn on, additionally, it was reported that the pump battery does not charge, despite the use of multiple usb cables and wall adapters.Customer¿s blood glucose level was not impacted.The customer reverted to an alternate method of insulin therapy.
 
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Brand Name
T:SLIM X2 INSULIN PUMP
Type of Device
PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
Manufacturer Contact
michael trier
8584011451
MDR Report Key15874819
MDR Text Key307469297
Report Number3013756811-2022-133143
Device Sequence Number1
Product Code OYC
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
P140015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 11/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1002717
Device Catalogue Number1002684-D
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received11/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2020
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 EthnicityNon Hispanic
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