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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 02/03/2021
Event Type  Injury  
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 customer experienced a blood glucose (bg) level of 23 mg/dl, respiratory distress, and a loss of consciousness. The cause of the low bg was unknown. Subsequently, customer was transported via ambulance to the hospital, and subsequently hospitalized in the intensive care unit. Customer was administered glucagon while being transported via ambulance, and once customer was hospitalized, treatment was administered via intravenous insulin, antibiotics, and customer was put on a breathing and feeding tube. Reportedly, the customer was released on (b)(6) 2021. Pump data review by tandem technical support confirmed the pump was functioning as intended. Customer reverted to manual injections for 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 Key11475720
MDR Text Key239502430
Report Number3013756811-2021-28281
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 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1000096
Device Catalogue Number1000898
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received03/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2019
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: 03/12/2021 Patient Sequence Number: 1
Treatment
INSULIN TYPE: NOVOLOG / NOVORAPIDINFUSION SET PRO
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