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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 Problem Insufficient Flow or Under Infusion (2182)
Patient Problem Injury (2348)
Event Date 07/31/2020
Event Type  Injury  
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 customer's blood glucose (bg) was 450 mg/dl and ketones were present (value not provided). Reportedly an "injury" occurred; however, no details were provided. An insulin pen was administered to address elevated bg and assistance was provided by the clinic nurse. Customer's parent alleged pump was faulty. Recommendation was made for contact to discuss event with their healthcare provider. Reportedly, customer reverted to an alternate method of insulin therapy. Although multiple attempts were made to obtain additional information, no response was received.

 
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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 Key10454371
MDR Text Key204379228
Report Number3013756811-2020-90398
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
PMA/PMN NumberP180008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Type of Report Initial,Followup
Report Date 08/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number1002717
Device Catalogue Number1004223
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/18/2020
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received02/08/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2019
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: 08/26/2020 Patient Sequence Number: 1
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