Accu-Chek ComboRecalls & reported problems across all models
Roche Diabetes Care GmbH · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,930
- Deaths reported
- 0
- Injuries reported
- 141
- Recalls
- 0
We found 3 models of Accu-Chek Combo by Roche Diabetes Care GmbH in the FDA's device registry (GUDID). Together they are named in 1,930 adverse event reports in the FDA's MAUDE database, received between Apr 4, 2016 and Mar 4, 2025 — classified as 141 injuries, 1,789 malfunctions.
The most frequently reported specific device problem is “Inaccurate Delivery” (543 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Accu-Chek Combo problems
Device problems
- Inaccurate Delivery543
- Inadequate User Interface537
- Fail-Safe Did Not Operate431
- Display Difficult to Read231
- Key or Button Unresponsive/not Working87
- Protective Measures Problem39
- Display or Visual Feedback Problem22
- Adverse Event Without Identified Device or Use Problem18
Patient problems
- No Clinical Signs, Symptoms or Conditions1,203
- Hyperglycemia541
- No Consequences Or Impact To Patient103
- Elevated Ketones/ Diabetic Ketoacidosis49
- Hypoglycemia38
- No Known Impact Or Consequence To Patient29
- Vomiting15
- Headache7
Accu-Chek Combo models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Accu-Chek Combo 05027250001Pump, Infusion, Insulin1,830 reports
- Accu-Chek Combo 05458544001Pump, Infusion, Insulin52 reports
- Accu-Chek Combo 05391512001Pump, Infusion, Insulin48 reports
Recent Accu-Chek Combo adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Roche Diabetes Care GmbH products
All Roche Diabetes Care GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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