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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fainting (1847)
Event Date 09/06/2020
Event Type  Injury  
Manufacturer Narrative
Per the tandem user guide: do not disconnect the tubing connector between the cartridge tubing and the infusion set tubing. If the connection comes loose, disconnect the infusion set from your body before tightening. 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 348 mg/dl, and customer fainted. Reportedly, customer disconnected at t:lock/luer lock. Bg was addressed via a correction bolus, and a supply change. Additionally, emergency medical technicians (emt) were called and assisted customer via taking vitals. Customer did not require additional treatment from emt's. Reportedly, the customer was instructed to consult with healthcare provider regarding bg level.
 
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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 Key10598913
MDR Text Key208915292
Report Number3013756811-2020-103504
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
Report Date 09/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1002717
Device Catalogue Number1005706
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 Received09/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2020
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: 09/29/2020 Patient Sequence Number: 1
Treatment
INSULIN: HUMALOG
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