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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

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TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND Back to Search Results
Model Number 1000096
Device Problems Filling Problem (1233); Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2022
Event Type  malfunction  
Event Description
It was reported that a minimum fill notification occurred after the user filled the cartridge with 300 units of insulin during the load sequence with multiple cartridges. Reportedly, the customer loaded cold insulin into the cartridge. A new cartridge was loaded to resolve the issue. There was no adverse impact on customer's blood glucose level.
 
Manufacturer Narrative
No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted.
 
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Brand NameT:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
Type of DeviceAUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
Manufacturer Contact
mick trier
san diego, CA 92121
8584011451
MDR Report Key14396688
MDR Text Key291626271
Report Number3013756811-2022-48586
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1000096
Device Catalogue Number1000886
Device Lot NumberM902272
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received04/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/13/2022 Patient Sequence Number: 1
Treatment
INSULIN: NOVOLOG/NOVORAPIDINFUSION SET: AUTOSOFT
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