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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 Partial Blockage (1065); Filling Problem (1233)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2022
Event Type  malfunction  
Manufacturer Narrative
The device has been received for evaluation; however, device evaluation is not yet complete. A supplemental report will be submitted upon completion of the evaluation.
 
Event Description
It was reported that insulin drips were intermittently not observed to be exiting the infusion set tubing during the load fill tubing process. Additionally, the customer had an unspecified cartridge issue. Reportedly, multiple supply changes were performed to address the issues; however, the issue persisted, and the customer reverted back to manual daily injections. Customer¿s blood glucose level was 228 mg/dl.
 
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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
Manufacturer Contact
mick trier
san diego, CA 92121
8584011451
MDR Report Key14396995
MDR Text Key291640368
Report Number3013756811-2022-49020
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1000096
Device Catalogue Number1000898
Device Lot Number60310046
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received06/03/2022
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: 05/13/2022 Patient Sequence Number: 1
Treatment
INSULIN: HUMALOGINFUSION SET: AUTOSOFT XC
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