Animas Vibe 11620200Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10840406100303), received between Jul 11, 2017 and Oct 25, 2018 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Read Input Signal” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2018Structural Problem; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS ALLEGED THAT THE BATTERY COMPARTMENT WAS DAMAGED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION HAS THE ABILITY TO 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 8004180 ↗
• MalfunctionJul 17, 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 078) 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 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 7695002 ↗
• MalfunctionJul 12, 2018Failure to Read Input Signal; Failure to Read Input Signal

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER ALLEGED THAT THE UP, DOWN, AND OK/ENTER BUTTON'S WERE UNDER RESPONSIVE ON THE KEYPAD. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE HAS THE ABILITY TO RESULT IN INADVERTENT OR INCORRECT INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7682228 ↗
• MalfunctionOct 19, 2017Structural Problem; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. THE REPORTER ALLEGED THAT THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION HAS THE ABILITY TO RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT OR THE CARTRIDGE COMPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6962931 ↗
• MalfunctionAug 9, 2017Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 052/053/054/055 SLEEP) ISSUE. THERE WAS NO INDICATION THAT THIS ISSUE LEAD TO AN ADVERSE EVENT. THIS 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 6777465 ↗
• MalfunctionAug 9, 2017Electrical /Electronic Property Problem; Moisture Damage; Electrical /Electronic Property Problem; Moisture Damage

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. IT WAS ALLEGED THAT THERE WAS MOISTURE BEHIND THE DISPLAY AND THERE WAS INTERMITTENT POWER. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE 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 6777296 ↗
• MalfunctionAug 8, 2017Failure to Read Input Signal; Failure to Read Input Signal

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE DOWN ARROW 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 INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6773914 ↗
• MalfunctionAug 8, 2017No Display/Image; Moisture Damage; No Display/Image; Moisture Damage

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (CLOUDY W/ MOISTURE) ISSUE. IT WAS REPORTED THAT MOISTURE WAS LOCATED BEHIND THE DISPLAY AND BEHIND THE IR WINDOW. 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 6773686 ↗
• MalfunctionAug 3, 2017Moisture Damage; Failure to Read Input Signal; Moisture Damage; Failure to Read Input Signal

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES WITH MOISTURE) ISSUE. THE REPORTER ALLEGED THE UP ARROW, DOWN ARROW, AND OK BUTTONS WERE UNDER RESPONSIVE, AND THE BATTERY COMPARTMENT HAD MOISTURE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE HAS THE ABILITY TO RESULT IN INADVERTENT OR INCORRECT INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6766161 ↗
• MalfunctionJul 13, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP HAD NO POWER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6710134 ↗
• MalfunctionJul 11, 2017Failure to Read Input Signal; Failure to Read Input Signal

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS WERE UNDER RESPONSIVE TO USER PRESSES. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE HAS THE ABILITY TO RESULT IN INADVERTENT OR INCORRECT INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6704892 ↗