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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); High Blood Pressure/ Hypertension (1908)
Event Date 06/07/2022
Event Type  Injury  
Manufacturer Narrative
No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted. Per tandem user guide: do not use any other insulin with your system other than u-100 humalog or u-100 novolog.
 
Event Description
It was reported that the customer went to the emergency room (er) and was subsequently hospitalized due to a blood glucose (bg) level of 422 mg/dl; cause was unknown. Reportedly, the customer had been using lyumjev insulin within the pump supplies. Tandem technical support informed customer that lyumjev insulin is off label per the user guide. Customer alleged the basal software did not function as intended, however upon review it was found that the basal feature was working as intended. Customer delivered a correction bolus via the pump to address bg. Bg was treated with intravenous fluids of insulin and saline, and a heart catheterization was performed. Customer was released from the hospital on (b)(6) 2022 with hypertension and no permanent damage. Upon release customer's bg level was in the 200 mg/dl range; customer started humalog insulin and was to consult with a healthcare provider regarding diabetes management.
 
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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 Key14876620
MDR Text Key295061915
Report Number3013756811-2022-68724
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 06/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1000096
Device Catalogue Number1000898
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received06/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2019
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: 06/30/2022 Patient Sequence Number: 1
Treatment
INSULIN: LYUMJEVINFUSION SET: AUTOSOFT 90
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