Animas Vibe 11851000Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10840406100570), received between Sep 7, 2016 and Oct 12, 2018 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2018Premature Discharge of Battery; Premature Discharge of Battery

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7960493 ↗
• MalfunctionJun 14, 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. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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 7600399 ↗
• MalfunctionApr 6, 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 7403275 ↗
• MalfunctionAug 24, 2017Temperature Problem; Temperature Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (TEMP - NO PHYSICAL DAMAGE) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE 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 6819505 ↗
• MalfunctionAug 22, 2017Defective Alarm; Defective Alarm

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A AUDIO TONE/VIBRATION (AUDIO TONE ISSUE) ISSUE. IT WAS ALLEGED THAT THE PUMP WAS BEEPING. THE REPORTER WAS NOT ABLE TO PROVIDE FURTHER INFORMATION DURING THE INITIAL COMPLAINT. CUSTOMER TECHNICAL SUPPORT MADE ATTEMPTS TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION AND TROUBLESHOOTING, WITHOUT SUCCESS. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE IS BEING REPORTED BECAUSE THE ISSUE MAY CAUSE THE USER TO MISS AN ALARM OR WARNING THAT MAY CAUSE CESSATION OF INSULIN DELIVERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6812542 ↗
• MalfunctionAug 4, 2017No Display/Image; No Display/Image

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) 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 AN INABILITY TO USE THE PRODUCT WHICH MAY LEAD TO LONG TERM CESSATION OF DELIVERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6768227 ↗
• MalfunctionJun 22, 2017Premature Discharge of Battery; Structural Problem; Premature Discharge of Battery; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ DAMAGE) ISSUE. IT WAS NOTED THAT THE BATTERY COMPARTMENT WAS CRACKED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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 6659803 ↗
• MalfunctionMar 6, 2017Device Issue; Device Issue

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. IT WAS ALLEGED THAT THE BASAL HISTORY DID NOT MATCH THE ACTIVE BASAL PROGRAM. IT WAS ALLEGED THAT THE PUMP CAUSED THE PATIENT TO HAVE A BLOOD GLUCOSE HIGHER THAN 250MG/DL BUT LESS THAN 500MG/DL WITHOUT SYMPTOMS. THIS COMPLAINT IS BEING REPORTED BECAUSE THERE WAS AN ISSUE WITH THE PUMP NOT PERFORMING AS INTENDED WITH REGARDS TO THE HISTORY OR THE SETTINGS MAY RESULT IN OVER OR UNDER DELIVERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382964 ↗
• MalfunctionFeb 20, 2017Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. IT WAS ALLEGED THAT THE BATTERY COMPARTMENT WAS CRACKED WITH 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 6344549 ↗
• InjuryDec 22, 2016Use of Device Problem; Use of Device Problem

  ON (B)(6) 2016 THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OVER 500MG/DL. THERE WERE NO REPORTED SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. REPORTEDLY, THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT AND REMAINED ON THE PUMP. THE REPORTER NOTED THAT THE PATIENT¿S HEALTHCARE PROVIDER HAD MADE BASAL RATE CHANGES ASSOCIATED WITH THE ALLEGED BG EXCURSION. CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP WITH THE REPORTER AND FOUND ALL SETTINGS AND HISTORIES WERE CORRECT; THE PUMP WAS FOUND TO BE DELIVERING ACCURATELY AS PROGRAMMED. THE REPORTER NOTED THAT THE PATIENT EXHIBITED SIGNS/SYMPTOMS OF ILLNESS NOT CAUSED BY THE BG EXCURSION, AND THAT THE USER HAD OVERRIDDEN BOLUS DOSAGE RECOMMENDATION(S) PROVIDED BY THE PUMP. THE PATIENT WAS REFERRED TO THEIR HEALTHCARE PROVIDER FOR DIABETES MANAGEMENT. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY, WITH USE ERROR AS A CONTRIBUTING FACTOR.

  Patient problems: Hyperglycemia

  MAUDE report 6198749 ↗
• MalfunctionOct 19, 2016Device Issue; Device Issue

  ON 10/03/2016, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP'S RECORDED BASAL HISTORY DID NOT MATCH THE ACTIVE BASAL PROGRAM. 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 6042767 ↗
• MalfunctionOct 16, 2016Inaccurate Delivery; Inaccurate Delivery

  ON (B)(6) 2016, A REPORTER CONTACTED ANIMAS ALLEGING THAT THERE WAS AN INACCURATE DELIVERY ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6032572 ↗
• MalfunctionSep 7, 2016Moisture Damage; Failure to Read Input Signal; Structural Problem; Moisture Damage; Failure to Read Input Signal; Structural Problem

  ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (AUDIO BOLUS BUTTON DAMAGE PRIOR TO TACTILE CHANGE WITH MOISTURE) ISSUE. THE REPORTER ALLEGED THE AUDIO BOLUS BUTTON WAS UNDER RESPONSIVE. THE AUDIO BOLUS BUTTON COVER WAS MISSING/PEELING PRIOR TO THIS OCCURRENCE. IT WAS ALSO ALLEGED THAT THERE WAS MOISTURE BEHIND THE DISPLAY SCREEN. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE 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 5934004 ↗