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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2, BASAL-IQ, MMOL/L AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

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TANDEM DIABETES CARE T:SLIM X2, BASAL-IQ, MMOL/L AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND Back to Search Results
Model Number 1002717
Device Problems Crack (1135); Poor Quality Image (1408)
Patient Problem Fall (1848)
Event Date 03/10/2021
Event Type  Injury  
Manufacturer Narrative
Device not returned.
 
Event Description
It was reported that the customer experienced low blood glucose (value not provided) and customer fell causing the pump touchscreen to crack. The bottom area of touchscreen was distorted. Customer was not injured and required no assistance. Customer drank juice to address low bg. Cause of low bg was not reported. Although multiple attempts were made, no additional information was provided.
 
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Brand NameT:SLIM X2, BASAL-IQ, MMOL/L
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 Key11599684
MDR Text Key243287514
Report Number3013756811-2021-36785
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
PMA/PMN Number
K201214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup,Followup
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1002717
Device Catalogue Number1006419
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2021
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received08/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2020
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: 03/31/2021 Patient Sequence Number: 1
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