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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 Problem Filling Problem (1233)
Patient Problems Hyperglycemia (1905); Renal Failure (2041); Diabetic Ketoacidosis (2364)
Event Date 02/03/2021
Event Type  Injury  
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. Device not returned.
 
Event Description
It was reported that insulin drips were not observed to be exiting the infusion set cannula during the load fill tubing process. Reportedly, a supply change was performed to address the issue, however the issue was not resolved. It was reported that the customer's blood glucose was (bg) of 550 mg/dl with diabetic ketoacidosis (dka). Customer administered manual injections to treat elevated bg and dka. Customer was hospitalized on (b)(6) 2021 and was given saline and insulin intravenously to treat elevated bg and dka. Customer was released from the hospital on (b)(6) 2021 with kidney failure. Reportedly customer reverted to an alternate form of insulin therapy.
 
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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 Key11398633
MDR Text Key234237550
Report Number3013756811-2021-25988
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,Followup
Report Date 03/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000096
Device Catalogue Number1000886
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received04/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2019
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: 03/02/2021 Patient Sequence Number: 1
Treatment
INSULIN: NOVOLOG / NOVORAPID
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