Accu-Chek Combo 05027250001Recalls & reported problems
Roche Diabetes Care GmbH · Accu-Chek Spirit Combo · Class 2
All models of Accu-Chek Combo (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Roche Accu-Chek Combo insulin pump has 1,830 adverse event reports on record, with no deaths and 130 injuries. Many reports describe inaccurate insulin delivery, buttons that stop working, the pump shutting off without an alert, and a hard-to-read display, and many patients reported high blood sugar. There were no reports in the last 12 months, compared with 71 in the year before. No recalls name this device.
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
- 1,830
- Deaths reported
- 0
- Injuries reported
- 130
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,830 adverse event reports that list this exact device (DI 04015630880119), received between Apr 4, 2016 and Mar 4, 2025 — classified as 130 injuries, 1,700 malfunctions.
The most frequently reported specific device problem is “Inaccurate Delivery” (522 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Inaccurate Delivery522
- Inadequate User Interface514
- Fail-Safe Did Not Operate383
- Display Difficult to Read226
- Key or Button Unresponsive/not Working87
- Protective Measures Problem39
- Display or Visual Feedback Problem22
- Adverse Event Without Identified Device or Use Problem17
Patient problems
- No Clinical Signs, Symptoms or Conditions1,197
- Hyperglycemia515
- No Consequences Or Impact To Patient53
- Elevated Ketones/ Diabetic Ketoacidosis47
- Hypoglycemia37
- Vomiting14
- No Known Impact Or Consequence To Patient13
- Headache7
Recent adverse event reports
The 25 most recent of 1,830 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT A BUTTON ON THE INFUSION DEVICE WAS DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21512276 ↗MalfunctionFeb 27, 2025Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT THE INFUSION DEVICE SHUT OFF WITHOUT FIRST PROVIDING AN ERROR OR ALERT MESSAGE.
Patient problems: Hyperglycemia
MAUDE report 21482306 ↗MalfunctionFeb 27, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT TWO BUTTONS ON THE INFUSION DEVICE WERE DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21482255 ↗MalfunctionFeb 27, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT A BUTTON ON THE INFUSION DEVICE WAS DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21482234 ↗MalfunctionFeb 24, 2025Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN. THIS RESULTED IN LOW BLOOD GLUCOSE VALUES OF 48 MG/DL AND ONE DAY LATER IN ELEVATED BLOOD GLUCOSE LEVELS OF 250 MG/DL.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 21444814 ↗InjuryFeb 21, 2025Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS. ON THE INCIDENT DAY, THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO HIGH BLOOD GLUCOSE LEVELS WHILE USING THE INFUSION DEVICE. UPON ADMISSION TO HOSPITAL, A BLOOD GLUCOSE TEST RESULTED IN 600 MG/DL. THE PATIENT EXPERIENCED SYMPTOMS LIKE TINGLING IN THE LEGS AND DIZZINESS. WHILE BEING IN HOSPITAL, THE PATIENT USED A HOSPITAL INSULIN PUMP. THE PATIENT WAS RELEASED AFTER ONE DAY.
Patient problems: Dizziness; Hyperglycemia
MAUDE report 21437545 ↗MalfunctionFeb 18, 2025Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT THE INFUSION DEVICE FAILED TO PROVIDE A MECHANICAL ERROR AND/OR CARTRIDGE ERROR OR ALERT MESSAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21398993 ↗MalfunctionFeb 13, 2025Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS.
Patient problems: Hyperglycemia
MAUDE report 21374415 ↗MalfunctionFeb 12, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE DISPLAY OF THE INFUSION DEVICE WAS DEFECTIVE. THERE WAS A BLACK STAIN ON THE DISPLAY AND THE INFORMATION DISPLAYED WAS BLURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21361812 ↗MalfunctionFeb 7, 2025Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS.
Patient problems: Hyperglycemia
MAUDE report 21332845 ↗MalfunctionFeb 4, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT A BUTTON ON THE INFUSION DEVICE WAS DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21303752 ↗MalfunctionJan 31, 2025Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS OF 400 MG/DL.
Patient problems: Hyperglycemia
MAUDE report 21285102 ↗MalfunctionJan 31, 2025Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT THE INFUSION DEVICE SHUT OFF WITHOUT FIRST PROVIDING AN ERROR OR ALERT MESSAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21284385 ↗MalfunctionJan 31, 2025Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT THE INFUSION DEVICE SHUT OFF WITHOUT FIRST PROVIDING AN ERROR OR ALERT MESSAGE SEVERAL TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21281811 ↗MalfunctionJan 30, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE DISPLAY OF THE INFUSION DEVICE WAS DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21275722 ↗MalfunctionJan 29, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE DISPLAY OF THE INFUSION DEVICE WAS DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21263898 ↗MalfunctionJan 29, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT A BUTTON ON THE INFUSION DEVICE WAS DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21262613 ↗MalfunctionJan 28, 2025Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS 35 MMOL/L.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21250868 ↗MalfunctionJan 28, 2025Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT THE INFUSION DEVICE SHUT OFF WITHOUT FIRST PROVIDING AN ERROR OR ALERT MESSAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21250229 ↗MalfunctionJan 27, 2025Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS OF 25 MMOL/L.
Patient problems: Hyperglycemia
MAUDE report 21245875 ↗MalfunctionJan 27, 2025Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS.
Patient problems: Hyperglycemia
MAUDE report 21241678 ↗MalfunctionJan 23, 2025Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT THE INFUSION DEVICE SHUT OFF WITHOUT FIRST PROVIDING AN ERROR OR ALERT MESSAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21218718 ↗MalfunctionJan 22, 2025Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS.
Patient problems: Hyperglycemia
MAUDE report 21207547 ↗MalfunctionJan 17, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT A BUTTON ON THE INFUSION DEVICE WAS DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21177149 ↗MalfunctionJan 17, 2025Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21177102 ↗
Other Pump, Infusion, Insulin devices
- Omnipod DASH Pod POD-BLE-11-520Insulet Corporation · Pump, Infusion, Insulin1 recall30 deaths56,209 reports
- Omnipod ZXP420Insulet Corporation · Pump, Infusion, Insulin1 recall17 deaths37,832 reports
- Omnipod ZXP420Insulet Corporation · Pump, Infusion, Insulin70 deaths20,092 reports
- t:slim X2 Insulin Pump 1000103Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin1 recall1 death7,327 reports
- t:slim Insulin Pump, Reconditioned Replacement 007262Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin2 deaths5,253 reports
- t:flex Insulin Pump, Replacement, Refurbished 007473Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin2 deaths2,373 reports
- t:slim Insulin Pump 007435Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin7 deaths2,104 reports
- t:slim X2 Insulin Pump 1000369Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin1 recall1,640 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page