Animas Vibe 11651400Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10840406100365), received between Aug 13, 2016 and Sep 6, 2018 — classified as 4 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Moisture Damage” (9 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 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; A CRACKED BATTERY COMPARTMENT AND INTERMITTENT POWER. 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 7850396 ↗
• MalfunctionSep 6, 2018Premature Discharge of Battery; Premature Discharge of Battery

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. THE REPORTER CLAIMED REPLACING THE BATTERY SEVERAL TIMES AND CONTINUALLY GETTING LOW BATTERY WARNINGS. 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 7850274 ↗
• MalfunctionJun 19, 2018Image Display Error/Artifact; Moisture Damage; Image Display Error/Artifact; Moisture Damage

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM WITH MOISTURE) 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 7615688 ↗
• MalfunctionJun 19, 2018Defective Alarm; Defective Alarm

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING THE VIBRATORY ALERT FUNCTION OF THE PUMP WOULD NOT STOP. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT 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 7613757 ↗
• MalfunctionMay 25, 2018Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. THE REPORTER ALLEGED MOISTURE WAS FOUND IN THE BATTERY COMPARTMENT. 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 7546257 ↗
• InjuryDec 11, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON (B)(6) 2017, THE PATIENT EXPERIENCED A BLOOD GLUCOSE OVER 600 MG/DL WITH ABDOMINAL PAIN AND LARGE KETONES ASSOCIATED WITH INTERMITTENT POWER TO THE PUMP. REPORTEDLY, THE PATIENT DISCONTINUED THE INSULIN PUMP AND WAS HOSPITALIZED AND TREATED WITH INSULIN VIA INJECTION AND IV FLUIDS. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA DUE TO AN ALLEGED INTERMITTENT POWER ISSUE.

  Patient problems: Abdominal Pain; Hyperglycemia

  MAUDE report 7103850 ↗
• MalfunctionNov 8, 2017Structural Problem; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS REPORTED THAT THE CARTRIDGE COMPARTMENT WAS CRACKED/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 CARTRIDGE COMPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7012287 ↗
• MalfunctionSep 28, 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 064) 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 6901493 ↗
• MalfunctionSep 21, 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 078) 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 6885525 ↗
• MalfunctionSep 18, 2017No Display/Image; No Display/Image

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6871484 ↗
• MalfunctionSep 12, 2017Moisture Damage; Moisture Damage

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED MOISTURE WAS PRESENT BEHIND THE DISPLAY AREA. 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 6857667 ↗
• MalfunctionSep 6, 2017Device Issue; Device Issue

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A OTHER (UNUSUAL ISSUE) ISSUE. THE REPORTER ALLEGED THE PATIENT WAS OFF THE PUMP "NOT MANAGING THE PUMP CORRECTLY". THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE MAY IMPACT INSULIN DELIVERY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6847515 ↗
• MalfunctionAug 30, 2017Premature Discharge of Battery; Moisture Damage; Premature Discharge of Battery; Moisture Damage

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE WITH MOISTURE) ISSUE. IT WAS ALLEGED THAT THERE WAS MOISTURE BEHIND THE DISPLAY. THE REPORTER WAS NOT ABLE TO PROVIDE FURTHER INFORMATION DURING THE INITIAL COMPLAINT. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE 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 6833341 ↗
• MalfunctionAug 22, 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 (CALL SERVICE ALARM ISSUE) ISSUE. 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. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6812555 ↗
• MalfunctionAug 21, 2017Device Issue; Device Issue

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. IT WAS REPORTED THAT THERE WAS AN INACCURATE DELIVERY ISSUE; THE BASAL HISTORY DID NOT MATCH ACTIVE BASAL PROGRAM. THE PATIENT¿S BASAL SETTING ¿WAS SUPPOSED TO BE AT 12:00 AM-6:00 AM .300, BUT SHOWED .200; AT 6:00 AM-12 AM .400, BUT INSTEAD SHOWED .300." THE PATIENT¿S BLOOD GLUCOSE (BG) WAS REPORTED TO BE 400 MG/DL WITH NO REPORTED ADDITIONAL SIGNS OR SYMPTOMS, WHICH DOES NOT MEET THE ANIMAS CRITERIA FOR AN ADVERSE EVENT. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED AS 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 6809384 ↗
• MalfunctionAug 21, 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 OK/ENTER 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 INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6808638 ↗
• MalfunctionAug 8, 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 NO 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 6776097 ↗
• MalfunctionAug 7, 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 W/MOISTURE) ISSUE. IT WAS REPORTED THAT THE UP ARROW, DOWN ARROW, AND OK BUTTONS WERE UNDER-RESPONSIVE AND THAT MOISTURE/CORROSION WAS LOCATED IN 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 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 6769985 ↗
• 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 6769118 ↗
• MalfunctionAug 4, 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. THERE IS NO INDICATION THAT THE PRODUCT ISSUE 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 6768996 ↗
• MalfunctionJul 24, 2017Failure to Sense; Failure to Sense

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. IT WAS ALLEGED THAT THERE WAS A FILLED CARTRIDGE IN THE PUMP AND THE PUMP WAS PRIMING THE TUBING DURING THE LOAD STEP. 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 INSULIN OVER DELIVERY IF THE PATIENT IS NOT DISCONNECTED DURING THE LOAD CARTRIDGE STEP. THE OWNER'S BOOKLET PROVIDES A WARNING TO THE USER TO NEVER START THE PRIME/REWIND SEQUENCE ON THE PUMP WHILE THE INFUSION SET IS CONNECT TO THE BODY AND PROVIDES MULTIPLE REMINDERS DURING THE PRIME/REWIND SEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6739287 ↗
• MalfunctionJul 21, 2017Moisture Damage; Moisture Damage

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) 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 6734771 ↗
• MalfunctionJul 14, 2017Premature Discharge of Battery; Moisture Damage; Premature Discharge of Battery; Moisture Damage

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ MOISTURE) ISSUE; MOISTURE BEHIND THE DISPLAY. 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. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6714103 ↗
• MalfunctionJul 11, 2017Structural Problem; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE) 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 6704970 ↗
• MalfunctionJun 8, 2017Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (LINE THROUGH DISPLAY) ISSUE. 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. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6628920 ↗