Animas Vibe 11820000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10840406100525), received between Jul 13, 2017 and Nov 9, 2018 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE REPORTER CONTACTED ANIMAS ON (B)(6) 2018 ALLEGING THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY EVIDENCED BY BLOOD GLUCOSE (BG) MEASURING 427MG/DL AND HAD VOMITING WITH MODERATE KETONES. THE PATIENT REPORTEDLY RECEIVED PHONE ADVICE FROM THE CLINIC ON HOW TO TREAT AND TOOK INSULIN VIA AN INJECTION. AFTER THE INJECTION, REPORTER ALLEGED A BG OF 35 MG/DL WITH NO REPORTED SYMPTOMS. THE REPORTER ALLEGED THE PUMP HAD A BLANK SCREEN WITH CONTINUAL START UP SOUNDS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY ASSOCIATED WITH AN ALLEGED PUMP MALFUNCTION OF INTERMITTENT POWER.

  Patient problems: Hyperglycemia; Vomiting

  MAUDE report 8056318 ↗
• MalfunctionSep 9, 2018Device Displays Incorrect Message; Communication or Transmission Problem; Fail-Safe Problem; Device Displays Incorrect Message; Communication or Transmission Problem; Fail-Safe Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (COMMUNICATION) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED 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 7858815 ↗
• MalfunctionNov 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 UP ARROW, DOWN ARROW, AND OK/ENTER BUTTONS WERE 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 7012396 ↗
• MalfunctionOct 20, 2017Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (LINE THROUGH DISPLAY) ISSUE. 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 6966501 ↗
• MalfunctionJul 13, 2017Structural 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 (B)(6) 2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6710032 ↗