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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 Obstruction of Flow (2423)
Patient Problems Fall (1848); Hyperglycemia (1905)
Event Date 11/22/2021
Event Type  Injury  
Event Description
It was reported that the customer experienced a blood glucose (bg) level of 1019 mg/dl resulting in a fall. Reportedly, an occlusion alarm occurred; however customer was unable to identify any identifiable issues with the pump or related supplies. The customer went to the emergency room and was subsequently hospitalized in the intensive care unit. Bg was treated with intravenous insulin and saline. Reportedly, the customer was released on (b)(6) 2021 with the issue resolved and no permanent damage.
 
Manufacturer Narrative
No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted.
 
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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 Key12972673
MDR Text Key282039679
Report Number3013756811-2021-136864
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 12/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number1000096
Device Catalogue Number1000898
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received11/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/09/2021 Patient Sequence Number: 1
Treatment
INSULIN: HUMALOG
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