Accu-Chek Combo 05458544001Recalls & reported problems
Roche Diabetes Care GmbH · Accu-Chek Combo Kit mg 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 is the Accu-Chek Combo insulin pump kit, which delivers insulin through a tube and has a built-in meter. Reports mostly describe the pump's safety shutoff not working, buttons and the display failing, and the pump delivering too much or too little insulin, sometimes without any alert, which several users link to high blood sugar. There are 52 reports, 6 injuries and no deaths. 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
- 52
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 04015630883806), received between Sep 9, 2019 and Aug 1, 2022 — classified as 6 injuries, 46 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (26 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 Operate26
- Inadequate User Interface14
- Inaccurate Delivery7
- Display Difficult to Read3
- Appropriate Device Problem Term/Code Not Available1
- Insufficient Device Problem Information1
Patient problems
- No Consequences Or Impact To Patient27
- Hyperglycemia13
- No Known Impact Or Consequence To Patient9
- Elevated Ketones/ Diabetic Ketoacidosis2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 1, 2022Inadequate 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 15141754 ↗MalfunctionFeb 18, 2022Inaccurate 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 13557598 ↗InjuryDec 8, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PATIENT'S DOCTOR REPORTED THE PATIENT WAS HOSPITALIZED ON (B)(6) 2021 WITH DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 413 MG/DL. THE PATIENT HAD NOT BEEN USING THE INFUSION DEVICE FOR AN UNDETERMINED AMOUNT OF TIME DUE TO AN UNKNOWN ERROR MESSAGE. HE WAS INITIALLY TREATED WITH AN IV OF NOVOLOG AND IS NOW USING INSULIN INJECTIONS. THE INFUSION DEVICE COULD NOT BE RETURNED BECAUSE THE DOCTOR WAS UNABLE TO PROVIDE ADDITIONAL PATIENT INFORMATION AND THE PATIENT WAS UNAVAILABLE AT THE TIME OF THE REPORT.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 12960206 ↗MalfunctionSep 15, 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 RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS.
Patient problems: Hyperglycemia
MAUDE report 12477605 ↗MalfunctionMar 3, 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. THE CUSTOMER HAD SYMPTOMS OF HIGH BLOOD SUGAR AND TESTED HER BLOOD SUGAR AT OVER 500 MG/DL ON HER AVIVA COMBO METER. THEN SHE LOOKED AT HER PUMP AND NOTICED IT WAS BLANK. AFTER CHANGING THE BATTERY THE PUMP POWERED ON. THE CUSTOMER USED THE PUMP BOLUS TO CORRECT HER HIGH BLOOD SUGAR.
Patient problems: Hyperglycemia
MAUDE report 11404946 ↗MalfunctionMar 3, 2021Display 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 11404265 ↗MalfunctionJan 27, 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 11237813 ↗MalfunctionDec 4, 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 10944336 ↗MalfunctionDec 1, 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 10927091 ↗MalfunctionOct 19, 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 10698192 ↗MalfunctionOct 15, 2020Inadequate User Interface; Inadequate User Interface
IT WAS REPORTED THAT TWO BUTTONS ON THE INFUSION DEVICE WERE DEFECTIVE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10683273 ↗MalfunctionOct 12, 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 10663282 ↗MalfunctionSep 25, 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 10589453 ↗MalfunctionSep 25, 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 10589446 ↗MalfunctionSep 17, 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 10547626 ↗MalfunctionAug 19, 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 10425541 ↗InjuryAug 18, 2020Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN RESULTING IN HYPERGLYCEMIA. THE CUSTOMER REPORTED THAT HIGH BLOOD GLUCOSE SYMPTOMS OF DEHYDRATION, LIGHTHEADEDNESS, VOMITING, AND CHILLS STARTED ON (B)(6) 2020. THE CUSTOMER ATTEMPTED TO SELF TREAT HER BLOOD GLUCOSE FOR SEVERAL DAYS BY ADMINISTERING CORRECTION BOLUSES AND INSULIN INJECTIONS. ON (B)(6) 2020 AT 7:30AM THE CUSTOMER RECEIVED A BLOOD GLUCOSE RESULT OF 360 MG/DL ON HER FORA BRAND METER. THE CUSTOMER HAD HER HUSBAND TAKE HER TO THE EMERGENCY ROOM AT 10:30AM ON (B)(6) 2020. THE CUSTOMER'S BLOOD GLUCOSE WAS TAKEN UPON ARRIVAL AT THE HOSPITAL, HOWEVER THE RESULT WAS UNKNOWN. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AND WAS TREATED WITH AN INSULIN IV AND OTHER IV FLUIDS. THE CUSTOMER WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2020 AT 10:30AM WITH A BLOOD GLUCOSE RESULT OF 98 MG/DL.
Patient problems: Hyperglycemia
MAUDE report 10422747 ↗MalfunctionJul 24, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE INFUSION DEVICE DISPLAYED THE POWER INTERRUPT ERROR MESSAGE WITHOUT ANY PRIOR ALERT/ERROR. THE POWER INTERRUPT ERROR MESSAGE OCCURRED RANDOMLY DURING THE MIDDLE OF THE NIGHT WITHOUT WARNING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10323091 ↗MalfunctionJul 24, 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 10320673 ↗MalfunctionJul 17, 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 10288438 ↗MalfunctionJul 14, 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 10272060 ↗MalfunctionJul 6, 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 10233047 ↗MalfunctionJun 19, 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 10173947 ↗MalfunctionMay 18, 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 10065322 ↗MalfunctionMay 13, 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 10051231 ↗
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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