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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2, BASAL-IQ, MG/DL AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

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TANDEM DIABETES CARE T:SLIM X2, BASAL-IQ, MG/DL AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND Back to Search Results
Model Number 1002717
Device Problem Obstruction of Flow (2423)
Patient Problems Fatigue (1849); Vomiting (2144); Diabetic Ketoacidosis (2364)
Event Date 07/28/2020
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.

 
Event Description

It was reported that the an occlusion alarm occurred. Contact changed the cartridge, infusion set and insulin to address occlusion. Contact did not observed any issues with the cartridge or infusion set. After supply change, contact alleged pump did not deliver insulin properly. Customer's blood glucose was greater than 300 mg/dl and ketone level was high. Customer was fatigued and was vomiting. Customer was transported via ambulance to the emergency room and was admitted to the hospital. Pump therapy was suspended and customer was treated with intravenous insulin. On (b)(6) 2020, customer's bg was 217 mg/dl. On july 31st (estimated date), customer was discharged with the elevated bg/ketones resolved; there was no permanent injury. Reportedly, upon discharge, customer reverted to using another pump for insulin therapy.

 
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Brand NameT:SLIM X2, BASAL-IQ, MG/DL
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 Key10437403
MDR Text Key203860413
Report Number3013756811-2020-87489
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
PMA/PMN NumberP180008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Type of Report Initial,Followup
Report Date 08/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number1002717
Device Catalogue Number1004219
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/01/2020
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received11/02/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2019
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: 08/21/2020 Patient Sequence Number: 1
Treatment
INFUSION SET: NOVORAPID, INFUSION SET: INSET
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