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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 Incorrect Measurement (1383)
Patient Problems High Blood Pressure/ Hypertension (1908); No Consequences Or Impact To Patient (2199)
Event Date 12/09/2019
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned; however, the device has not yet been received. A supplemental report will be submitted if the device is received.
 
Event Description
It was reported that the insulin gauge was inaccurate. Customer¿s blood glucose was 250-500 mg/dl. Reportedly the high bg level was cause when pump stopped delivering insulin due to occlusion alarm. Reportedly the customer changed infusion sets and performed manual injection to address the high bg issue. Reportedly, the customer had manual injections available as alternate insulin therapy.
 
Manufacturer Narrative
The investigation has been completed. Based on the analysis, the alleged malfunction was identified in the pump logs; however, no failure was identified. Additionally, a different issue was identified. (i. E. Occlusion alarms, altitude alarms, auto-off alarms).
 
Event Description
Customer's blood glucose level was 250 mg/dl.
 
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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 Key9482563
MDR Text Key171650991
Report Number3013756811-2019-94810
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00853052007264
UDI-Public00853052007264
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,Followup,Followup
Report Date 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000096
Device Catalogue Number1000886
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received01/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2018
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: 12/17/2019 Patient Sequence Number: 1
Treatment
INFUSION SET: TRUSTEEL, INSULIN: NOVOLOG/NOVORAPID
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