Animas Vibe 13920000 (UDI 10840406103106)Recalls & reported problems

Summary

The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 10840406103106), received between May 22, 2017 and Jan 6, 2020 — classified as 4 injuries, 119 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (31 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

Recent adverse event reports

The 25 most recent of 123 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2020Failure to Read Input Signal; Failure to Read Input Signal

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (ABB TACTILE CNG/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE AUDIO BOLUS BUTTON WAS UNDER-RESPONSIVE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE HAS THE ABILITY TO RESULT IN INADVERTENT OR INCORRECT BOLUSES WHICH MAY RESULT IN OVER OR UNDER DELIVERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9552734 ↗
• MalfunctionJan 2, 2020Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. IT WAS ALLEGED THAT THE DISPLAY WAS DIM. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY IMPACT THE USER'S ABILITY TO READ SOME OR ALL OF THE INFORMATION ON THE SCREEN WHICH MAY RESULT IN OVER OR UNDER DELIVERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9539364 ↗
• MalfunctionJul 11, 2019Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) 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 IMPACT THE USER'S ABILITY TO READ SOME OR ALL THE INFORMATION ON THE SCREEN WHICH MAY RESULT IN OVER OR UNDER DELIVERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8779983 ↗
• MalfunctionJul 11, 2019Moisture Damage; Structural Problem; Moisture Damage; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CASE DAMAGE W/MOISTURE) ISSUE; CRACKED BATTERY COMPARTMENT WITH MOISTURE INSIDE THE BATTERY COMPARTMENT. THE REPORTER DENIED DAMAGE TO THE TO BATTERY CAP. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION CAN RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT OR CARTRIDGE COMPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8779965 ↗
• MalfunctionJul 11, 2019Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) ISSUE. THE REPORTER WAS NOT ABLE TO IDENTIFY THE CALL SERVICE ALARM THAT REPORTEDLY OCCURRED AND STATED THEY RECEIVED SEVERAL ALARMS THAT SAID "EMERGENCY CALL YOU GUYS" AND "REMOVE BATTERY TO SILENCE THE ALARM." 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 8779952 ↗
• MalfunctionJul 11, 2019No Display/Image; Moisture Damage; No Display/Image; Moisture Damage

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE; MOISTURE REPORTED IN THE BATTERY COMPARTMENT. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY IMPACT THE USER'S ABILITY TO READ SOME OR ALL THE INFORMATION ON THE SCREEN WHICH MAY RESULT IN OVER OR UNDER DELIVERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8779933 ↗
• MalfunctionJun 19, 2019Structural Problem; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; A CRACKED CARTRIDGE COMPARTMENT. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION CAN RESULT IN A DELAY IN TREATMENT OR LONG-TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT OR CARTRIDGE COMPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712944 ↗
• MalfunctionJun 12, 2019Moisture Damage; Moisture Damage

  ON (B)(6) 2019 THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE; MOISTURE IN THE BATTERY COMPARTMENT. THE REPORTER DENIED DAMAGE TO PUMP. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION CAN RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT OR CARTRIDGE COMPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8691378 ↗
• MalfunctionApr 15, 2019Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THE PUMP EXPERIENCED A CALL SERVICE 078 ALARM THAT WAS NOT ABLE TO BE CLEARED FROM THE PUMP. 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 8515504 ↗
• MalfunctionFeb 7, 2019Structural Problem; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A BATTERY COMPARTMENT CRACK. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10-OCT-2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8316741 ↗
• MalfunctionJan 22, 2019No Display/Image; Moisture Damage; No Display/Image; Moisture Damage

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (CLOUDY W/ MOISTURE) ISSUE; MOISTURE BEHIND THE DISPLAY SCREEN WITH A CLOUDY SCREEN. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY IMPACT THE USER'S ABILITY TO READ SOME OR ALL THE INFORMATION ON THE SCREEN WHICH MAY RESULT IN OVER OR UNDER DELIVERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8266757 ↗
• MalfunctionJan 18, 2019Structural Problem; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; CRACKED BATTERY COMPARTMENT. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION CAN RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT OR CARTRIDGE COMPARTMENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8261382 ↗
• MalfunctionJan 14, 2019Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE; A CRACKED BATTERY COMPARTMENT WITH NO POWER. THE REPORTER DENIED DAMAGE TO THE BATTERY CAP. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8245120 ↗
• MalfunctionJan 8, 2019Temperature Problem; Temperature Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (TEMP - NO PHYSICAL DAMAGE) ISSUE. THE REPORTER ALLEGED THE PATIENT WOKE UP WITH THE PUMP BEEPING AND THE PUMP FELT HOT TO THE TOUCH. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THERE IS THE POTENTIAL FOR THE USER TO EXPERIENCE AN INJURY TO THE SKIN DUE TO INCREASED PUMP TEMPERATURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8228105 ↗
• MalfunctionJan 4, 2019Structural Problem; Structural Problem

  ON (B)(6) 2018, THE CUSTOMER CONTACTED ANIMAS ALLEGING HEARING A RATTLE FROM INSIDE THE PUMP. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION CAN RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT OR CARTRIDGE COMPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8218513 ↗
• MalfunctionJan 2, 2019No Display/Image; Structural Problem; No Display/Image; Structural Problem

  THE REPORTER CONTACTED ANIMAS ON (B)(6) 2018 ALLEGING THE DISPLAY LENS WAS CRACKED. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY IMPACT THE USER'S ABILITY TO READ SOME OR ALL THE INFORMATION ON THE SCREEN WHICH MAY RESULT IN OVER OR UNDER DELIVERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8209152 ↗
• MalfunctionDec 20, 2018Structural Problem; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; A CRACKED BATTERY COMPARTMENT. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION CAN RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT OR CARTRIDGE COMPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8183978 ↗
• MalfunctionDec 17, 2018Structural Problem; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; CRACKED BATTERY COMPARTMENT. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION CAN RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT OR CARTRIDGE COMPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8170447 ↗
• MalfunctionNov 29, 2018Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 064) ISSUE THAT OCCURRED DURING THE REWIND/LOAD STEP. 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 8115476 ↗
• MalfunctionNov 27, 2018Moisture Damage; Structural Problem; Moisture Damage; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP W/MOISTURE) ISSUE. THE REPORTER ALLEGED THAT THE CARTRIDGE CAP WAS NOT ABLE TO REMAIN SECURED TO THE PUMP PROPERLY AND THERE WAS MOISTURE BEHIND THE DISPLAY SCREEN MAKING IT LOOK CLOUDY. THE REPORTER ALSO MENTIONED THE DISPLAY LENS WAS SCRATCHED, BUT THE SCRATCHES DID NOT PREVENT THE SCREEN FROM BEING READ. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION CAN RESULT IN A DELAY IN TREATMENT OR LONG-TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT OR CARTRIDGE COMPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8106374 ↗
• MalfunctionNov 26, 2018Partial Blockage; Device Displays Incorrect Message; Partial Blockage; Device Displays Incorrect Message

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A OCCLUSION (FREQUENT/PERSISTENT) ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO A REPORTABLE 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 8103070 ↗
• MalfunctionNov 26, 2018Partial Blockage; Device Displays Incorrect Message; Partial Blockage; Device Displays Incorrect Message

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A OCCLUSION (OCCLUSION ISSUE) 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 8102986 ↗
• MalfunctionOct 26, 2018Partial Blockage; Device Displays Incorrect Message; Partial Blockage; Device Displays Incorrect Message

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A OCCLUSION (FREQUENT/PERSISTENT) ISSUE. IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED WITH FOUR DIFFERENT SETS OF NEW INFUSION SETS AND CARTRIDGES. 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 8009448 ↗
• MalfunctionOct 24, 2018Failure to Read Input Signal; Failure to Read Input Signal

  ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT THE KEYPAD BUTTONS WERE UNDER RESPONSIVE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE HAS THE ABILITY TO RESULT IN AN INADVERTENT OR INCORRECT INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP. THE REPORTER DID STATE THAT THE PATIENT HAD A BLOOD GLUCOSE OF 273 MG/DL WITH SYMPTOMS OF EXCESS URINATION. THE ALLEGED BLOOD GLUCOSE EXCURSION DOES NOT MEET ANIMAS CRITERIA FOR A SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8000093 ↗
• MalfunctionOct 17, 2018Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. THE REPORTER ALLEGED AN INTERMITTENT POWER ISSUE WITH A CRACK IN THE BATTERY COMPARTMENT AND THE BATTERY CAP NOT SECURING PROPERLY TO THE PUMP. THE REPORTER DENIED DAMAGE TO THE BATTERY CAP AND STATED THE CAP HAD NEVER BEEN REPLACED. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7973577 ↗