• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Battery Problem (2885)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 04/14/2019
Event Type  Injury  
Manufacturer Narrative
No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the pump battery was observed to be depleting rapidly. The customer provided a blood glucose (bg) range of 10-300 mg/dl and indicated that the customer was known to experience low bg events. Reportedly, the customer experienced a seizure due to low bg and required assistance to consume glucose as treatment. Multiple contact attempts were made by tandem technical support to determine the rate of battery depletion and to obtain additional information regarding the cause of the low bg; however, the customer did not respond.
 
Manufacturer Narrative
Tandem quality engineer evaluated pump data and concluded the following: "blood glucose (bg) values below 54 mg/dl were recorded by continuous glucose monitor (cgm) from 10:57-11:12 pm on (b)(6) 2019. Cgm alert 3 (cgm glucose reading below user threshold) and cgm alert 1 (cgm low alert) were annunciated. Cartridge change sequence was completed at 10:54 am with 11. 3 units being primed through the infusion set tubing. User made bolus requests without entering current bg and while still having insulin on board (iob). At 9:36 pm, user requested a 3. 29 unit bolus for 46 grams of carbohydrates without entering current bg and while having 1. 77 units of insulin on board. There were no erratic basal rate adjustments. There is no evidence that the pump experienced a malfunction or failure. If user did not disconnect during the ¿fill tubing¿ step of the cartridge change sequence, insulin would be delivered, and this could cause bg levels to drop. Making bolus requests without entering current bg and while still having iob could lead to a low bg event. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
julia kensick
11075 roselle st.
san diego, CA 92121
8583666900
MDR Report Key8672736
MDR Text Key147150907
Report Number3013756811-2019-31379
Device Sequence Number1
Product Code OZO
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 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000096
Device Catalogue Number1000912
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received08/30/2019
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: 06/05/2019 Patient Sequence Number: 1
-
-