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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 1002717
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2022
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 the cartridge was bent at the canister, interrupting insulin delivery.Customer¿s blood glucose level was not impacted.Reportedly, a new cartridge was loaded to address the issue.
 
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Brand Name
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
Type of Device
AUTOMATED 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 Key14349365
MDR Text Key291326687
Report Number3013756811-2022-46452
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K201214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1002717
Device Catalogue Number1007420
Device Lot Number60309763
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received04/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2021
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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