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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 1000354
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Convulsion/Seizure (4406)
Event Date 08/25/2021
Event Type  Injury  
Manufacturer Narrative
And paramedics were called.Despite the device registering 40, a blood glucose value these and related issues, including months prior to these events.Case number = (b)(4).Supervisors were involved.The most recent event on (b)6) 2021 prompted another call to dexcom.Despite being told to ask for a supervisor, no supervisor was available within the entire united states.My call was routed to the (b)(6).Eventually, after email communication, i received a call days later.No intervention or suggestion was offered.I was informed that i would get a call back, but have not.I was made to believe that my calls were reported to the fda.Have you received reports from dexcom? type i diabetics and their families should be made aware of the fact that the stop in insulin delivery will not necessarily prevent a dangerously low blood sugar value.They should also know that not all low reading are accurate, but all cause alarm and intervention/ assessment, particularly when the patient is unable to wake or care for him/herself.Also, these problems lead to insulin dosages/pump setting that on a day-to day basis force blood sugar levels to run consistently high, so as to avoid a medical emergency/911 call.This leads to elevated hemoglobin a1c levels, which unfortunately leads to the onset of debilitating, long-term complications.See above.Fda safety report id # (b)(4)." no product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.
 
Event Description
Voluntary medwatch was received via us mail: "there are 2 problems: one: dexcom sensor/transmitter does not consistently provide accurate readings - requiring 911 calls for assistance.When a type i diabetic is alone, sleeping, unable to wake to standard alarms and phone calls, and bs values drops and remain at dangerously low levels (40, lowest value the dexcom device can read).These events occurred in a type i diabetic with a history of many hypoglycemic-induced seizures, all which have occurred upon waking, some necessitating glucagon, some a trip to the emergency room, and some causing a slow return to normal cognition.This history of hypo-glycemic-induced seizures led the patient/family to the new dexcom and tandem technology, but it is not consistently accurate/reliable, raising concerns about its efficacy in preventing significant adverse events in type i diabetics.On (b)(6) 21 the police entered the patient's locked dorm room and assisted by waking the patient and providing fast acting carbohydrate.No additional intervention was required.Two: the tandem pump that communicates with the dexcom devices turns off appropriately but does not stop the drop in bs values necessitating intervention from someone other than the patient (b)(6) 21 (parent), (b)(6) 2021 police/paramedic).On (b)(6) 2021 dexcom device registered approximately 130 from 6-7:30 am.By 8 am the value dropped to 78, pump stopped delivery, 15 grams of carbohydrate was given by parent, things stabilized for about 1/2 hour, but then suddenly dropped to 54, despite the pump remaining off (no basal insulin delivery) and no bolus of insulin given for approximately 10 plus hours.Further details - on other occasions, the drop in blood sugar as noted on the dexcom was not accurate (b) (6) 2021).On (bx6) the patient eventually woke to repeated calls and confirmed that the level was not 40, but within an acceptable range.On (b)(6) 2021, the patient did not wake to alarms or phone calls, so police.
 
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Brand Name
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
Type of Device
AUTOMATED 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 Key12844923
MDR Text Key281330890
Report Number3013756811-2021-126325
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00850006613731
UDI-Public00850006613731
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 Other
Type of Report Initial
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1000354
Device Catalogue Number1006379
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 11/01/2021
Initial Date FDA Received11/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient EthnicityNon Hispanic
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