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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 Hyperglycemia (1905); Myocardial Infarction (1969); Visual Impairment (2138)
Event Date 05/13/2019
Event Type  Injury  
Manufacturer Narrative
Per tandem¿s t:slim x2 g6 user guide: ¿do not use any other insulin with your system other than u-100 humalog or u-100 novolog. Only humalog and novolog have been tested and found to be compatible for use in the system. " no product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted. Device not returned.
 
Event Description
It was reported that the customer experienced a blood glucose (bg) level of 1100 mg/dl and diabetic ketoacidosis. Reportedly, the customer had experienced vomiting due to e. Coli food poisoning. The customer and healthcare provider were unsure of the cause of elevated bg; however noted that it may have been related to the food poisoning. The customer went to the emergency room and was subsequently hospitalized. Bg was treated with intravenous insulin and fluids. Reportedly, the customer was released on (b)(6) 2019 with the issue resolved. Reportedly, elevated bg impacted customer's heart requiring customer to use beta-blocker medication (type of heart condition was not specified). Customer also noted that vision impairment as a result of elevated bg. Reportedly, customer was using fiasp insulin. Tandem technical support educated the customer on insulin labeling. Customer acknowledged.
 
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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
julia kensick
11075 roselle st.
san diego, CA 92121
8583666900
MDR Report Key8945934
MDR Text Key155999284
Report Number3013756811-2019-54984
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P180008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 08/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1000096
Device Catalogue Number1000886
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received08/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2019
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: 08/29/2019 Patient Sequence Number: 1
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