Accu-Chek Spirit Cartridge 04949935001Recalls & reported problems
Roche Diabetes Care GmbH · Accu-Chek Spirit 3.15ml Cart. Sys. 5pcs · Class 2
All models of Accu-Chek Spirit Cartridge (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Accu-Chek Spirit insulin cartridge holds insulin for an insulin pump. Reports mostly describe insulin leaking into the pump's cartridge compartment, with some mentioning high blood sugar and a hospital stay after high then low blood sugar. There are 69 reports that name its identifier, with no deaths and 4 injuries. 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
- 69
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 04015630882755), received between Sep 12, 2019 and Jul 17, 2024 — classified as 4 injuries, 65 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (68 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 Leak68
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- No Consequences Or Impact To Patient24
- Hyperglycemia9
- No Known Impact Or Consequence To Patient4
- Elevated Ketones/ Diabetic Ketoacidosis1
- Hypoglycemia1
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
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 ↗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 16, 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 19116221 ↗MalfunctionApr 8, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN BETWEEN THE CARTRIDGE AND THE ADAPTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19059350 ↗MalfunctionMar 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 18832668 ↗MalfunctionDec 20, 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 18364924 ↗MalfunctionDec 11, 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 18301888 ↗MalfunctionNov 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THE USER ALLEGED THAT A LEAKAGE OCCURRED WITH TWO CARTRIDGES FROM THE SAME BOX/LOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18094172 ↗MalfunctionNov 7, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN AT THE PLUNGER DURING THE FILLING PROCESS. THIS ISSUE OCCURRED WITH 21 CARTRIDGES FROM THE SAME LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18082822 ↗MalfunctionOct 27, 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 18022314 ↗MalfunctionSep 20, 2023Fluid/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. THIS ISSUE OCCURRED WITH 5 INSULIN CARTRIDGES FROM THE SAME LOT NUMBER.
Patient problems: Hyperglycemia
MAUDE report 17784063 ↗MalfunctionJul 12, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE WAS LEAKY. THE LEAKAGE WAS OBSERVED AT THE CONNECTION BETWEEN THE CARTRIDGE AND THE ADAPTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17305970 ↗MalfunctionJun 1, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17036318 ↗MalfunctionApr 5, 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 16680244 ↗InjuryFeb 3, 2023Fluid/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 BLOOD GLUCOSE RESULTS WERE NOT PROVIDED. THE PATIENT WAS ADMITTED INTO THE HOSPITAL. THE TYPE OF TREATMENT PROVIDED TO THE PATIENT AT THE HOSPITAL WAS NOT PROVIDED. IT IS UNKNOWN HOW LONG THE PATIENT WAS IN THE HOSPITAL.
Patient problems: Hyperglycemia
MAUDE report 16296050 ↗MalfunctionNov 21, 2022Fluid/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 15837192 ↗MalfunctionOct 10, 2022Fluid/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 15572162 ↗MalfunctionAug 30, 2022Fluid/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 15324671 ↗MalfunctionJul 28, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THE LEAKAGE WAS OBSERVED AT THE CONNECTION BETWEEN THE CARTRIDGE AND THE INFUSION SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15122924 ↗MalfunctionJun 28, 2022Fluid/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 14844177 ↗MalfunctionJun 7, 2022Fluid/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 14620102 ↗MalfunctionMay 16, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PISTON ROD OF THE INFUSION DEVICE WAS WET AS IF INSULIN LEAKED FROM THE CARTRIDGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14408910 ↗MalfunctionMay 5, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE IS AN INSULIN LEAKAGE BETWEEN THE CARTRIDGE AND INFUSION TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14289732 ↗MalfunctionApr 1, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INSULIN CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE.
Patient problems: Hyperglycemia
MAUDE report 13978583 ↗
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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