Animas 2.0 mL Cartridge 10012402Recalls & reported problems
Animas Corporation · CARTRIDGE, STAMPED (ETO STERILE SGL) · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Animas 2.0 mL insulin pump cartridge is the subject of 1,043 adverse event reports, which mention no deaths and 118 injuries. Most reports describe the cartridge failing to prime, which can stop insulin from flowing, along with fluid leaks and blockages. Some mention high blood sugar. 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
- 1,043
- Deaths reported
- 0
- Injuries reported
- 118
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,043 adverse event reports that list this exact device (DI 10840406100136), received between Aug 7, 2016 and Sep 3, 2020 — classified as 118 injuries, 925 malfunctions.
The most frequently reported specific device problem is “Failure to Prime” (769 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
- Failure to Prime769
- Fluid/Blood Leak102
- Device Displays Incorrect Message61
- Use of Device Problem57
- Partial Blockage36
- Device Issue29
- Fail-Safe Problem25
- Pumping Problem8
Patient problems
- No Consequences Or Impact To Patient918
- Hyperglycemia109
- Polydipsia23
- Nausea21
- Lethargy16
- Urinary Frequency / Polyuria16
- Abdominal Pain10
- Confusion/ Disorientation10
Recent adverse event reports
The 25 most recent of 1,043 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2020Failure to Prime; Failure to Prime
ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10490753 ↗MalfunctionSep 3, 2020Failure to Prime; Failure to Prime
ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10489859 ↗MalfunctionJul 28, 2020Failure to Prime; Failure to Prime
ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM. THIS COMPLAINT IS ON THE INSULIN CARTRIDGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10335124 ↗InjuryJan 21, 2020Use of Device Problem; Use of Device Problem
ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 267 MG/DL WITH INCREASED URINATION, INCREASED DROWSINESS, INCREASED THIRST AND BLURRED VISION ASSOCIATED WITH A LOSS OF PRIME ISSUE. REPORTEDLY, THE PATIENT REMAINED ON THE PUMP AND WAS TREATED WITH 4 UNITS OF INSULIN ADMINISTERED BY THE PATIENT'S HUSBAND. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS NOTED THAT PATIENT WAS USING EXPIRED CARTRIDGES. IT WAS ALSO NOTED THAT THE PATIENT HAD A SUBSEQUENT LOW BLOOD GLUCOSE OF 39 MG/DL WITH DIZZINESS AND BEING UNSTEADY ON FEET AFTER HUSBAND ADMINISTERED 4 UNITS OF INSULIN. THIS PI IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING AN ADVERSE EVENT AS A RESULT OF USER ERROR FROM THE PATIENT USING EXPIRED CARTRIDGES.
Patient problems: Blurred Vision; Dizziness; Fatigue
MAUDE report 9612507 ↗MalfunctionDec 6, 2019Fluid/Blood Leak; Fluid/Blood Leak
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A SITE/SET/CART (AIR BUBBLES/LEAK) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PRESENCE OF AIR BUBBLES IN THE CARTRIDGE CAN RESULT IN UNDER DELIVERY. THIS COMPLAINT IS FOR THE INSULIN PUMP CARTRIDGE ONLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9426998 ↗InjuryJun 28, 2019Use of Device Problem; Use of Device Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING AFTER THEY PRIME THE PUMP, THE CARTRIDGE STARTS TO FILL UP WITH AIR. THE PATIENT REPORTEDLY EXPERIENCED HYPERGLYCEMIA WITH BLOOD GLUCOSE RANGING BETWEEN 250-300 MG/DL WITH ADDITIONAL SYMPTOMS OF SMALL URINARY KETONES, ABDOMINAL PAIN, NAUSEA, AND TREMORS. THE PATIENT RECEIVED TELEPHONE ADVISE FROM THEIR PHYSICIAN INSTRUCTING THEM TO DRINK LOTS OF WATER. THE BASAL SETTINGS WERE ADJUSTED BY THE PHYSICIAN. TROUBLESHOOTING COMPLETED BY ANIMAS CUSTOMER SUPPORT REVEALED THE PATIENT WAS FILLING THE INSULIN CARTRIDGE WITH COLD INSULIN OUT OF THE REFRIGERATOR WITHOUT BEING BROUGHT TO ROOM TEMPERATURE FIRST AS ADVISED IN THE MANUFACTURER'S INSTRUCTIONS FOR USE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY ASSOCIATED WITH USER ERROR.
Patient problems: Abdominal Pain; Hyperglycemia; Nausea
MAUDE report 8745453 ↗InjuryJun 28, 2019Partial Blockage; Device Displays Incorrect Message; Partial Blockage; Device Displays Incorrect Message
ON (B)(6) 2019, THE REPORTER ALLEGED THE PUMP WAS EMITTING OCCLUSION ALARMS AND THE PATIENT DISCONTINUED INSULIN PUMP THERAPY DUE TO THE OCCLUSION ALARMS AND NOT HAVING ANOTHER INFUSION SET TO CONNECT TO BECAUSE SHE NEEDED TO CHANGE OUT THE INFUSION SET. DURING TROUBLESHOOTING WITH ANIMAS CUSTOMER SUPPORT, IT WAS DISCOVERED THE PATIENT WAS USING THE INFUSION SET FOR LONGER THAN INSTRUCTED BY THE MANUFACTURER PER THE INSTRUCTIONS FOR USE (FOUR DAYS INSTEAD OF THE ADVISED THREE-DAY MAXIMUM) AND THE PATIENT WAS ALSO RE-USING THE INSULIN CARTRIDGES, WHICH IS AGAINST THE MANUFACTURER¿S INSTRUCTIONS FOR USE. THESE ACTIONS CONSTITUTE A TRAINING/MISUSE ISSUE ON THE PART OF THE PATIENT. THE REPORTER STATED THE PATIENT ALLEGED THAT AFTER HAVING DISCONTINUED INSULIN DELIVERY WITH THE INSULIN PUMP AS DESCRIBED ABOVE, THEY EXPERIENCED ELEVATED BLOOD GLUCOSE OF 370 MG/DL WITH ADDITIONAL SYMPTOMS OF DYSPNEA, POLYDIPSIA AND POLYURIA, NAUSEA, LETHARGY AND ADDITIONAL SYMPTOMS SUGGESTIVE OF DEHYDRATION. THE PATIENT REPORTEDLY PROVIDED SELF-TREATMENT ¿PER USUAL METHOD.¿ THE REPORTER CONFIRMED THE PATIENT DID NOT RECEIVE TREATMENT OVER OR ABOVE THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. NO FURT
Patient problems: Dyspnea; Lethargy; Polydipsia
MAUDE report 8745132 ↗MalfunctionJun 4, 2019Structural Problem; Structural Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT THE PUMP EMITTED MULTIPLE LOSS OF PRIME WARNINGS WHILE CARTRIDGES FROM THE SAME BOX WERE IN USE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE IS BEING REPORTED BECAUSE IT MAY RESULT IN A LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8666149 ↗MalfunctionMay 3, 2019Failure to Prime; Failure to Prime
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THE PUMP EMITTED WARNING THAT THE PUMP WAS NOT PRIMED. THE REPORTER DECLINED TO COMPLETE TROUBLESHOOTING WITH ANIMAS CUSTOMER SUPPORT AT THE TIME OF THE CALL. ANIMAS CUSTOMER SUPPORT MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW UP TO COMPLETE TROUBLESHOOTING OF THE ISSUE; HOWEVER, THE REPORTER DID NOT RESPOND. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG-TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8577315 ↗MalfunctionApr 25, 2019Failure to Prime; Failure to Prime
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THE PUMP HAD BEEN GIVING WARNINGS THAT THE PUMP WAS NOT PRIMED. THE REPORTER WAS UNABLE TO COMPLETE TROUBLESHOOTING WITH ANIMAS CUSTOMER TECHNICAL SUPPORT AT THE TIME THE COMPLAINT WAS MADE. ANIMAS CUSTOMER TECHNICAL SUPPORT MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW-UP TO COMPLETE TROUBLESHOOTING OF THE ISSUE; HOWEVER, THE REPORTER DID NOT RESPOND. NO FURTHER INFORMATION IS AVAILABLE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG-TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8548843 ↗MalfunctionApr 19, 2019Fluid/Blood Leak; Fluid/Blood Leak
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A SITE/SET/CART (AIR BUBBLES/LEAK) ISSUE. THE REPORTER ALLEGED THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE MEASURING 389 MG/DL WITH LETHARGY WHILE ON INSULIN PUMP THERAPY. THIS COMBINATION OF BLOOD GLUCOSE LEVEL AND SYMPTOM DOES NOT MEET ANIMAS¿ CRITERIA OF A REPORTABLE ADVERSE EVENT. THEREFORE, NO ADVERSE EVENT IS BEING REPORTED IN ASSOCIATED WITH THIS COMPLAINT. THE REPORTER ALLEGED THE DEVELOPMENT OF AIR BUBBLES IN THE INSULIN CARTRIDGE AFTER THE CARTRIDGE WAS LOADED INTO THE PUMP AND FURTHER REPORTED THE STRONG ODOR OF INSULIN INSIDE THE CARTRIDGE COMPARTMENT, ALLEGING THE CARTRIDGE WAS LEAKING INSULIN. ANIMAS CUSTOMER SUPPORT COMPLETED TROUBLESHOOTING OF THE CARTRIDGE ISSUE WITH THE REPORTER AND DETERMINED THERE WAS NO USE ERROR INVOLVED AND THE CARTRIDGE HAD BEEN PREPARED BY THE USER ACCORDING TO THE INSTRUCTIONS FOR USE. THE SUBJECT CARTRIDGE WAS DISCARDED BY THE USER AND NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PRESENCE OF AIR BUBBLES IN THE CARTRIDGE OR LEAKAGE CAN RESULT IN UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8531343 ↗MalfunctionApr 16, 2019Fluid/Blood Leak; Fluid/Blood Leak
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A SITE/SET/CART (AIR BUBBLES/LEAK) ISSUE AT THE END OF CARTRIDGE USE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PRESENCE OF AIR BUBBLES IN THE CARTRIDGE CAN RESULT IN UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8518326 ↗InjuryApr 9, 2019Fluid/Blood Leak; Fluid/Blood Leak
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT EXPERIENCED A BLOOD GLUCOSE GREATER THAN 250MG/DL, BUT LESS THAN 500MG/DL, WITH A HEADACHE, ABDOMINAL PAIN, AND LARGE KETONES, ASSOCIATED WITH AN ALLEGED CARTRIDGE LEAK. REPORTEDLY, THE PATIENT REMAINED ON THE PUMP, AND SELF-TREATED WITH INSULIN VIA INJECTION. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS REVEALED THE BOD OF THE CARTRIDGE WAS CRACKED, AND WAS LEAKING INSULIN INTO THE CARTRIDGE COMPARTMENT. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH A LEAKING CARTRIDGE ISSUE.
Patient problems: Abdominal Pain; Headache; Hyperglycemia
MAUDE report 8496385 ↗MalfunctionApr 9, 2019Failure to Prime; Failure to Prime
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG-TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8495995 ↗MalfunctionApr 8, 2019Failure to Prime; Failure to Prime
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG-TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8492591 ↗MalfunctionApr 2, 2019Failure to Prime; Failure to Prime
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING AN ISSUE WITH LOSS OF PRIME TWO TIMES WITHIN ONE WEEK. NO FURTHER INFORMATION WAS PROVIDED AND THE REPORTER WAS NOT ABLE TO TROUBLESHOOT THE ISSUE WITH ANIMAS CUSTOMER TECHNICAL SUPPORT (CTS). CTS ATTEMPTED TO CONTACT THE REPORTER AGAIN MULTIPLE TIMES TO COMPLETE THE TROUBLESHOOTING OF THE ISSUE, BUT THE REPORTER DID NOT RESPOND. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG-TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8473421 ↗MalfunctionMar 27, 2019Failure to Prime; Failure to Prime
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG-TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8456603 ↗MalfunctionFeb 21, 2019Failure to Prime; Failure to Prime
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG-TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8359072 ↗MalfunctionFeb 20, 2019Fluid/Blood Leak; Fluid/Blood Leak
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A SITE/SET/CART (AIR BUBBLES/LEAK) ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PRESENCE OF AIR BUBBLES IN THE CARTRIDGE CAN RESULT IN UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8353679 ↗MalfunctionFeb 13, 2019Failure to Prime; Failure to Prime
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT THE PUMP EMITTED LOSS OF PRIME WARNINGS WITH CARTRIDGE IN USE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8334832 ↗MalfunctionFeb 6, 2019Failure to Prime; Failure to Prime
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG-TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8310143 ↗MalfunctionFeb 4, 2019Failure to Prime; Failure to Prime
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THE PUMP HAD BEEN LOSING PRIME SINCE THE CUSTOMER GOT THE PUMP. NO FURTHER INFORMATION WAS AVAILABLE. TROUBLESHOOTING WAS NOT COMPLETED. ANIMAS CUSTOMER SUPPORT MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW-UP HOWEVER, THE CUSTOMER WAS NOT ABLE TO SPEAK WITH CUSTOMER SUPPORT REGARDING THE ALLEGED LOSS OF PRIME ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG-TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8302250 ↗MalfunctionFeb 4, 2019Failure to Prime; Failure to Prime
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG-TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8300763 ↗MalfunctionJan 22, 2019Failure to Prime; Failure to Prime
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. THE REPORTER STATED ALL THE INSULIN CARTRIDGES INVOLVED HAVE BEEN DISCARDED. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG-TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8266398 ↗MalfunctionJan 8, 2019Failure to Prime; Failure to Prime
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT THE PUMP EMITTED MULTIPLE LOSS OF PRIME WARNINGS WHILE THE SAME CARTRIDGE WAS IN USE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THIS ISSUE MAY RESULT IN A LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8228021 ↗
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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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