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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 Problems Pumping Stopped (1503); Charging Problem (2892)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2021
Event Type  malfunction  
Event Description
It was reported that the customer received a power source alert after plugging the pump into a wall outlet.Subsequently, the pump battery could not be charged.Additionally, it was reported that the pump shut off unexpectedly.Customer confirmed pump display turned on when plugged into a power source.The customer reverted to manual injections for insulin therapy.Customer's blood glucose was 128 mg/dl.
 
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Brand Name
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
Type of Device
AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
MDR Report Key11274656
MDR Text Key230121569
Report Number3013756811-2021-09182
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00853052007301
UDI-Public(01)00853052007301
Combination Product (y/n)N
PMA/PMN Number
P180008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1000096
Device Catalogue Number1000898
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2021
Was the Report Sent to FDA? Yes
Date Manufacturer Received02/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
INFUSION SET: AUTOSOFT XC, INSULIN: HUMALOG; INFUSION SET: AUTOSOFT XC, INSULIN: HUMALOG
Patient Age66 YR
Patient Weight82
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