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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 Filling Problem (1233)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/02/2022
Event Type  malfunction  
Event Description
It was reported that insulin drips were not observed to be exiting the infusion set tubing during the load fill tubing process. Reportedly, the cartridge was changed to address the issue and insulin delivery was resumed. Customer's blood glucose ranged from 324-325 mg/dl.
 
Manufacturer Narrative
Device not returned.
 
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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 Key14210539
MDR Text Key290108695
Report Number3013756811-2022-37956
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K201214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 04/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1002717
Device Catalogue Number1004223
Device Lot NumberW788607
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received04/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2020
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: 04/26/2022 Patient Sequence Number: 1
Treatment
INFUSION SET: AUTOSOFT 90, INSULIN: NOVOLOG/NOVORA
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