t:slim X2 Insulin Pump with Basal-IQ 1000886Recalls & reported problems
Tandem Diabetes Care, Inc. · t:slim X2 Insulin Pump with Basal-IQ, 6.0 · Class 3
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is a Tandem t:slim X2 insulin pump with Basal-IQ. Its reports mostly describe pump stoppages, wrong screen messages, inaccurate readings and charging trouble. There are 108,657 reports, including 17 deaths and 8,908 injuries. One recall, started in May 2022, is open: memory faults, an inaccurate battery display and a touchscreen that stays on. Reports dropped to 271 in the last 12 months, from 838 before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 108,656
- Deaths reported
- 17
- Injuries reported
- 8,908
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 108,656 adverse event reports that list this exact device (DI 00853052007264), received between Oct 31, 2018 and Sep 29, 2026 — classified as 17 deaths, 8,908 injuries, 99,731 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (19,953 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- May 24, 2022Open, Classified
Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a software update. Issues could result in hypoglycemia, hyperglycemia or diabetic ketoacidosis.
Z-1811-2022 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Pumping Stopped19,953
- Device Displays Incorrect Message13,526
- Incorrect Measurement12,235
- Charging Problem11,480
- Obstruction of Flow9,405
- Failure to Sense8,260
- Battery Problem7,917
- Adverse Event Without Identified Device or Use Problem5,964
Patient problems
- No Clinical Signs, Symptoms or Conditions45,809
- No Consequences Or Impact To Patient36,007
- No Known Impact Or Consequence To Patient18,150
- Hyperglycemia4,627
- Hypoglycemia3,755
- Elevated Ketones/ Diabetic Ketoacidosis971
- Insufficient Information182
- No Patient Involvement115
Recent adverse event reports
The 25 most recent of 108,656 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938238 ↗MalfunctionSep 29, 2026Incorrect Measurement
It was reported that the battery gauge was inaccurate. There was no reported impact to the customer's blood glucose level. No additional information was provided and the customer declined troubleshooting with Tandem Technical Support.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933987 ↗MalfunctionSep 29, 2026Incorrect Measurement
It was reported that the battery gauge was fluctuating. There was no reported impact to the customer's blood glucose level. No additional information was provided and the customer declined troubleshooting with Tandem Technical Support.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933955 ↗MalfunctionSep 28, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924214 ↗MalfunctionSep 28, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920942 ↗MalfunctionAug 20, 2026Fitting Problem
It was reported that cartridge was often loose during use. There was no reported impact to the customer¿s blood glucose level. Customer declined further troubleshooting, and no additional corrective actions or outcomes were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356152 ↗MalfunctionAug 20, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50350361 ↗MalfunctionAug 20, 2026Premature Discharge of Battery
It was reported that the pump battery was depleting quickly. There was no reported impact to the customer's blood glucose level. No additional information was provided and the customer declined troubleshooting with Tandem Technical Support.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50348999 ↗InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM WITH A BLOOD GLUCOSE (BG) LEVEL OF 600 MG/DL WITH KETONES OF AN UNSPECIFIED SIZE ON APPROXIMATELY ON (B)(6) 2026 (SPECIFIC DATE NOT PROVIDED). CAUSE WAS NOT KNOWN. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN TO ADDRESS THE ELEVATED BG. CUSTOMER WAS DISCHARGED LATER THE SAME DAY WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE.
Patient problems: Hyperglycemia
MAUDE report 25778053 ↗MalfunctionJul 8, 2026Incorrect Measurement
IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FOLLOW-UP FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25751250 ↗MalfunctionJul 8, 2026Premature Discharge of Battery
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FOLLOW-UP FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25750673 ↗InjuryJul 7, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED MULTIPLE TIMES; DETAILS AND NATURE OF EVENT WERE NOT PROVIDED. REPORTEDLY, THE CUSTOMER ALLEGED THAT PUMP WAS "FAILING". MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO FOLLOW-UP WITH THE CUSTOMER ON THE REPORTED ISSUE, BUT NO RESPONSE WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 25732932 ↗MalfunctionJul 6, 2026Incorrect Measurement
IT WAS REPORTED THAT PUMP INITIALLY DISPLAYING AN INCORRECT INSULIN AMOUNT BEFORE UPDATING. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED FOLLOW-UP FROM TECHNICAL SUPPORT, AND NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING ANY FURTHER ACTIONS OR RESOLUTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25720166 ↗MalfunctionJul 6, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PUMP SCREEN WAS DARK AND WOULD NOT TURN ON. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. NO ADDITIONAL INFORMATION WAS PROVIDED AND THE CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25717032 ↗MalfunctionJul 6, 2026Premature Discharge of Battery
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT. THERE WAS NO REPORTED ADVERSE IMPACT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25716325 ↗MalfunctionJul 6, 2026Premature Discharge of Battery
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT. THERE WAS NO REPORTED ADVERSE IMPACT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25715383 ↗MalfunctionJul 2, 2026Display or Visual Feedback Problem
IT WAS REPORTED A "HAZY SCREEN ON PUMP". CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25696340 ↗MalfunctionJul 2, 2026Obstruction of Flow
IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO GATHER ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25695933 ↗MalfunctionJun 30, 2026Premature Discharge of Battery
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FOLLOW-UP FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25667427 ↗MalfunctionJun 29, 2026Date/Time-Related Software Problem
IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. CUSTOMER DECLINED TO TROUBLESHOOT THE ISSUE WITH TANDEM TECHNICAL SUPPORT; THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25652690 ↗MalfunctionJun 26, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CONTINUOUS GLUCOSE MONITOR ERROR 42. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. THE CUSTOMER WAS INSTRUCTED TO RESET THE PUMP TO RESOLVE THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25640205 ↗MalfunctionJun 26, 2026Premature Discharge of Battery; Pumping Stopped
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY RESULTING IN THE PUMP SHUTTING OFF. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. MULTIPLE ATTEMPTS WERE MADE BY TANDEM¿S TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25633122 ↗MalfunctionJun 25, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25630644 ↗MalfunctionJun 25, 2026Break
IT WAS REPORTED THAT A CARTRIDGE DID NOT FIT ONTO THE PUMP. REPORTEDLY, THERE WAS AN O-RING FROM A PREVIOUS CARTRIDGE ON THE PNEUMATIC TAP. ADDITIONALLY, IT WAS REPORTED THAT THE O-RING WAS MISSING FROM THE CARTRIDGE THAT THE CUSTOMER WAS INTENDING TO LOAD. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. AN ADDITIONAL NEW CARTRIDGE WAS LOADED TO RESOLVE THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25623733 ↗MalfunctionJun 25, 2026Pumping Stopped
A MALFUNCTION WAS REPORTED ON THE PUMP, AND IT DISPLAYED A NON-RESETTABLE MALFUNCTION CODE, WITH NO NOTABLE EVENTS OCCURRING BEFORE ISSUE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25621462 ↗
Other Automated Insulin Dosing , Threshold Suspend devices
- MiniMed® 630G MMT-1715KMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend4 recalls98 deaths35,170 reports
- t:slim X2 Insulin Pump with Basal-IQ 1000912Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall2 deaths30,219 reports
- t:slim X2 Insulin Pump with Basal-IQ 1000898Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall6 deaths16,106 reports
- MiniMed® 630G MMT-1715KMMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend2 recalls50 deaths9,892 reports
- MiniMed® 630G MMT-1715KMedtronic Minimed, Inc. · Automated insulin dosing , threshold suspend4 recalls36 deaths7,947 reports
- MiniMed® 530G MMT-751NASMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend36 deaths7,479 reports
- MiniMed®630G MMT-1715KMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend2 recalls17 deaths6,645 reports
- t:slim X2 Insulin Pump with Basal-IQ 1000892Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall1 death5,216 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.