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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 Fall (1848); Hyperglycemia (1905); Injury (2348)
Event Date 12/06/2019
Event Type  Injury  
Manufacturer Narrative

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 was vomiting and experienced an elevated blood glucose (bg) level of 1,000mg/dl; suspected cause was unknown. Additionally, the customer fell and sustained an injury. Reportedly, the customer was unsure if pump was worn at the time of the incident. The customer required assistance in being taken to the hospital after sustaining an additional fall. The customer was subsequently admitted to the hospital where a feeding tube, as well as manual injections of insulin were used to resolve the issue. Reportedly, the customer was released from the hospital on (b)(6) 2019 with the issue resolved, and no permanent damage.

 
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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 Key9571348
MDR Text Key174409337
Report Number3013756811-2020-05543
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP180008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 01/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
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 Received12/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2019
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: 01/09/2020 Patient Sequence Number: 1
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