Accu-Chek Spirit CartridgeRecalls & reported problems across all models
Roche Diabetes Care GmbH · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 99
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 2 models of Accu-Chek Spirit Cartridge by Roche Diabetes Care GmbH in the FDA's device registry (GUDID). Together they are named in 99 adverse event reports in the FDA's MAUDE database, received between Sep 5, 2019 and Jul 23, 2024 — classified as 4 injuries, 95 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (98 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 Spirit Cartridge problems
Device problems
- Fluid/Blood Leak98
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions49
- No Consequences Or Impact To Patient26
- Hyperglycemia17
- No Known Impact Or Consequence To Patient6
- Elevated Ketones/ Diabetic Ketoacidosis1
- Hypoglycemia1
Accu-Chek Spirit Cartridge models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Accu-Chek Spirit Cartridge 04949935001Pump, Infusion, Insulin69 reports
- Accu-Chek Spirit Cartridge 05206073001Pump, Infusion, Insulin30 reports
Recent Accu-Chek Spirit Cartridge adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THE INSULIN LEAK OCCURRED WITH 8 CARTRIDGES FROM THE SAME PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19808034 ↗MalfunctionJul 17, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT INSULIN LEAKED INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS.
Patient problems: Hyperglycemia
MAUDE report 19761492 ↗InjuryJul 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT INSULIN WAS LEAKING FROM THE INSULIN CARTRIDGE INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THE PATIENT SUFFERED FROM HYPERGLYCEMIA, ADMINISTERED TOO MUCH INSULIN AND WENT INTO HYPOGLYCEMIA. THE EXACT BLOOD GLUCOSE VALUES ARE NOT KNOWN. THE USER WAS TAKEN TO HOSPITAL AND HOSPITALIZED FOR FOUR DAYS. THE PATIENT'S DOCTOR CITED THE PUMP AS THE CAUSE OF THE LEAKAGE. THE TREATMENT ADMINISTERED AT THE HOSPITAL IS UNKNOWN.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 19749718 ↗MalfunctionJul 11, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19725417 ↗MalfunctionJul 11, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THE INSULIN LEAK APPEARED AT THE CONNECTION WITH THE PISTON ROD. THIS ISSUE OCCURRED WITH TWO INSULIN CARTRIDGES FROM THE SAME PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19717875 ↗MalfunctionJul 9, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN BETWEEN THE CONNECTION OF THE CARTRIDGE AND THE INFUSION TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19704623 ↗MalfunctionJul 8, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS.
Patient problems: Hyperglycemia
MAUDE report 19689420 ↗MalfunctionJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS.
Patient problems: Hyperglycemia
MAUDE report 19665501 ↗MalfunctionJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN BETWEEN THE ADAPTER AND INFUSION TUBING RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS. THE PATIENT'S BLOOD GLUCOSE LEVEL INCREASED TO 300 MG/DL. THE INSULIN LEAK OCCURRED WITH CARTRIDGES FROM THE SAME PACKAGE. IT IS UNKNOWN HOW MANY CARTRIDGES WERE DEFECTIVE. THE PATIENT THINKS THE INSULIN CARTRIDGE WAS THE CAUSE OF THE LEAKAGE.
Patient problems: Hyperglycemia
MAUDE report 19665471 ↗MalfunctionJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS. THE ISSUE HAS OCCURRED FOR SEVERAL WEEKS. IT IS UNKNOWN HOW MANY CARTRIDGES WERE DEFECTIVE.
Patient problems: Hyperglycemia
MAUDE report 19665467 ↗MalfunctionJun 7, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT INSULIN WAS LEAKING OUT OF THE STOPPER AT THE BACK OF THE INSULIN CARTRIDGE. THE INSULIN LEAK OCCURRED WITH 5 CARTRIDGES FROM THE SAME LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19485162 ↗MalfunctionJun 7, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS.
Patient problems: Hyperglycemia
MAUDE report 19483163 ↗MalfunctionJun 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS. THE ISSUE OCCURRED WITH TWO CARTRIDGES.
Patient problems: Hyperglycemia
MAUDE report 19459845 ↗MalfunctionJun 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19459391 ↗MalfunctionApr 25, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19180395 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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