Accu-Chek Spirit Cartridge 05206073001Recalls & reported problems
Roche Diabetes Care GmbH · Accu-Chek Spirit 3.15ml Cart. Sys. 25pc · Class 2
All models of Accu-Chek Spirit Cartridge (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is an Accu-Chek Spirit insulin cartridge used with an insulin pump. The 30 reports mostly describe insulin leaking out of the cartridge — into the pump's cartridge compartment, at the piston rod connection, or between the cartridge and the infusion tubing — sometimes across several cartridges from the same package, and in some cases blood sugar rose as a result. No deaths and no injuries were reported. There are no recalls naming 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
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04015630882908), received between Sep 5, 2019 and Jul 23, 2024 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (30 reports).
1 other recall cover devices cleared under the same FDA submission (K042887); they may or may not involve this specific model.
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
- Fluid/Blood Leak30
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Hyperglycemia8
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 25 most recent of 30 reports, 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 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 ↗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 ↗MalfunctionApr 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN DUE TO A CRACK ON THE CARTRIDGE 2 TO 3 WEEKS AGO. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19116063 ↗MalfunctionApr 8, 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 19067000 ↗MalfunctionApr 8, 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 19066885 ↗MalfunctionApr 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 19043250 ↗MalfunctionMar 26, 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 18977141 ↗MalfunctionMar 22, 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 18960548 ↗MalfunctionJan 24, 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 18569095 ↗MalfunctionDec 18, 2023Fluid/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 18350670 ↗MalfunctionDec 6, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THIS ISSUE OCCURRED WITH FIVE CARTRIDGES OF THE SAME LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18274637 ↗MalfunctionNov 15, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE REPEATEDLY LEADING TO ELEVATED BLOOD GLUCOSE LEVELS.
Patient problems: Hyperglycemia
MAUDE report 18140034 ↗MalfunctionOct 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THE ISSUE ALSO OCCURRED WITH CARTRIDGE FROM ANOTHER PACK WITH THE SAME LOT NUMBER.
Patient problems: Hyperglycemia
MAUDE report 17956060 ↗MalfunctionOct 13, 2023Fluid/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 17930646 ↗MalfunctionOct 12, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THE CALLER ALLEGED THAT THIS OCCURRED WITH TWO CARTRIDGES FROM THE SAME BOX/LOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17923132 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K042887. One submission often covers many models, so check the product and lot details in each record.
- Z-1734-2015 · Apr 22, 2015 · TerminatedAccuChek Spirit insulin infusion pump.
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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