Accu-Chek Combo 05391512001Recalls & reported problems
Roche Diabetes Care GmbH · Accu-Chek Spirit Combo Repl. US/en · 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 Spirit Combo insulin pump delivers insulin continuously through a cartridge. The 48 reports mostly describe the pump stopping without giving any warning or error message, alarms that stopped working, buttons that no longer respond, and pumps delivering too much or too little insulin, which led to high blood sugar. Five reports involve injuries and no deaths are described. No recalls name this device, and no reports were filed in the past 12 months.
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
- 48
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 04015630883479), received between Sep 10, 2019 and May 11, 2022 — classified as 5 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (22 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.
Most reported problems
Device problems
- Fail-Safe Did Not Operate22
- Inaccurate Delivery14
- Inadequate User Interface9
- Display Difficult to Read2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Consequences Or Impact To Patient23
- Hyperglycemia13
- No Known Impact Or Consequence To Patient7
- No Clinical Signs, Symptoms or Conditions5
- Fatigue1
- Hypoglycemia1
- Vomiting1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
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 14361100 ↗MalfunctionJan 26, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE VIBRA-ALARM AND ACOUSTIC ALERT IN THE INFUSION DEVICE WERE NO LONGER FUNCTIONING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13359844 ↗MalfunctionJan 6, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
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 13176545 ↗MalfunctionNov 1, 2021Inaccurate 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 12727805 ↗MalfunctionJul 20, 2021Inadequate User Interface; Inadequate User Interface
IT WAS REPORTED THAT A BUTTON ON THE INFUSION DEVICE WAS DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12199417 ↗MalfunctionJul 20, 2021Inadequate User Interface; Inadequate User Interface
IT WAS REPORTED THAT A BUTTON ON THE INFUSION DEVICE WAS DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12198854 ↗InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL DUE TO HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF HI MG/DL (> 600 MG/DL). THE PATIENT AND THE PATIENT'S NURSE STATED THAT THE PUMP TRIGGERED ERROR MESSAGE E10 (=CARTRIDGE ERROR), WHICH WAS UNCLEARABLE. THE USER WAS TREATED WITH INSULIN INTRAVENOUSLY. AT THE TIME OF THE CALL, THE PATIENT WAS STILL IN THE HOSPITAL AND IT WAS UNCERTAIN WHEN SHE WOULD BE DISCHARGED.
Patient problems: Fatigue; Hyperglycemia; Vomiting
MAUDE report 11959404 ↗MalfunctionJan 14, 2021Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE INFUSION DEVICE SHUT OFF WITHOUT FIRST PROVIDING AN ERROR OR ALERT MESSAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11170921 ↗MalfunctionJan 12, 2021Inadequate User Interface; Inadequate User Interface
IT WAS REPORTED THAT A BUTTON ON THE INFUSION DEVICE WAS DEFECTIVE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11156862 ↗MalfunctionNov 23, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE INFUSION DEVICE SHUT OFF WITHOUT FIRST PROVIDING AN ERROR OR ALERT MESSAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10888439 ↗MalfunctionOct 27, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE INFUSION DEVICE SHUT OFF WITHOUT FIRST PROVIDING AN ERROR OR ALERT MESSAGE RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10740674 ↗MalfunctionSep 17, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE INFUSION DEVICE SHUT OFF WITHOUT FIRST PROVIDING AN ERROR OR ALERT MESSAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10545345 ↗MalfunctionSep 2, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE INFUSION DEVICE SHUT OFF WITHOUT FIRST PROVIDING AN ERROR OR ALERT MESSAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10481059 ↗MalfunctionAug 14, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE INFUSION DEVICE SHUT OFF WITHOUT FIRST PROVIDING AN ERROR OR ALERT MESSAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10406710 ↗MalfunctionAug 3, 2020Inadequate User Interface; Inadequate User Interface
IT WAS REPORTED THAT A BUTTON ON THE INFUSION DEVICE WAS DEFECTIVE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10359085 ↗MalfunctionJul 16, 2020Inadequate User Interface; Inadequate User Interface
IT WAS REPORTED THAT A BUTTON ON THE INFUSION DEVICE WAS DEFECTIVE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10284747 ↗MalfunctionJun 30, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE INFUSION DEVICE SHUT OFF WITHOUT FIRST PROVIDING AN ERROR OR ALERT MESSAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10211543 ↗MalfunctionJun 29, 2020Inaccurate 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; Hypoglycemia
MAUDE report 10209012 ↗MalfunctionMay 5, 2020Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN AS THE BASAL RATE SETTINGS WERE CHANGED TO 0.0 UNITS PER HOUR, ALTHOUGH THE CUSTOMER STATES THE BASAL RATE WAS PREVIOUSLY SET CORRECTLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10025159 ↗MalfunctionMay 5, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE INFUSION DEVICE SHUT OFF WITHOUT FIRST PROVIDING AN ERROR OR ALERT MESSAGE RESULTING IN ELEVATED BLOOD GLUCOSE.
Patient problems: Hyperglycemia
MAUDE report 10025095 ↗MalfunctionMar 31, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE ACOUSTIC ALERT IN THE INFUSION DEVICE WAS NO LONGER FUNCTIONING AFTER THE BATTERY WAS CHANGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9903299 ↗MalfunctionMar 27, 2020Inadequate User Interface; Inadequate User Interface
IT WAS REPORTED THAT A BUTTON ON THE INFUSION DEVICE WAS DEFECTIVE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9889801 ↗MalfunctionMar 27, 2020Display Difficult to Read; Display Difficult to Read
IT WAS REPORTED THAT THE DISPLAY OF THE INFUSION DEVICE WAS DEFECTIVE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9889751 ↗MalfunctionMar 24, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE INFUSION DEVICE POWERED OFF WITHOUT PROVIDING AN ERROR OR ALERT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9874392 ↗MalfunctionMar 22, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE INFUSION DEVICE SHUT OFF WITHOUT FIRST PROVIDING AN ERROR OR ALERT MESSAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9863744 ↗
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
- Accu-Chek Combo 05027250001Roche Diabetes Care GmbH · Pump, Infusion, Insulin1,830 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.
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