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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 Bruise/Contusion (1754); Hypoglycemia (1912)
Event Date 11/03/2019
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 customer experienced low blood glucose (bg) of 31 mg/dl; cause was unknown. Reportedly, the customer fell and sustained a bruise due to low bg. Paramedics administered glucagon to treat bg level. Additionally, the customer consumed food to treat bg level. Recommendation was made to consult with healthcare provider regarding diabetes management.
 
Manufacturer Narrative
Tandem quality engineer evaluated pump data and concluded the following: an alert 48 (cgm no readings alert) enunciated at 12:17:27 pm on 10/31/2019 indicating a temporary sensor failure ¿---" for more than 20 minutes. This issue resulted in no cgm readings again until 11/5/2019. Therefore, no cgm readings were observed on 11/1/2019. The lowest bg entered into the pump by the user on 11/3/2019 was 150 mg/dl. Therefore, the complaint cannot be confirmed. A tubing fill of size 19. 9 units was observed on 11/3/2019 at 8:04:15 am. 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. On 11/3/2019, user made bolus requests while still having insulin on board (iob). Making bolus requests while still having iob could lead to a low bg event. Allowing the cgm sensor session to be in a ¿---" state prevents the user from continuously monitoring bg and potentially addressing an impending low bg. There is no evidence that the pump experienced a malfunction or failure.
 
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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
MDR Report Key9315853
MDR Text Key166175249
Report Number3013756811-2019-82031
Device Sequence Number1
Product Code OZO
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 11/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1000096
Device Catalogue Number1000898
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received04/08/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/13/2019 Patient Sequence Number: 1
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