Animas Vibe 11420400Recalls & reported problems

Summary

The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 10840406100020), received between Aug 10, 2016 and Sep 14, 2020 — classified as 10 injuries, 109 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (35 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 25 most recent of 119 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2020Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) ISSUE. IT WAS NOTED THAT THE PUMP EMITTED A CS 069 SERVICE ALARM. 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 10528171 ↗
• MalfunctionNov 27, 2018Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2018, 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 8106047 ↗
• MalfunctionNov 2, 2018Pumping Problem; Pumping Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A OTHER (UNUSUAL ISSUE) ISSUE. IT WAS REPORTED THAT THE PUMP WAS NOT WORKING PROPERLY OR DELIVERING INSULIN. THE REPORTER ALSO ALLEGED THAT THE PUMP KEPT BEEPING. CUSTOMER TECHNICAL SUPPORT WAS UNABLE TO TROUBLESHOOT AT THE TIME OF THE CALL AS IT WAS ALSO REPORTED THAT THE PUMP WAS UNAVAILABLE AS IT WAS LOST. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION AGAINST THE DELIVERY FUNCTION OF THE PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8032883 ↗
• MalfunctionOct 12, 2018Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) 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 7960672 ↗
• MalfunctionJan 10, 2018Structural Problem; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 15-DEC-2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7179163 ↗
• MalfunctionJan 5, 2018Electrical /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 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 7168207 ↗
• MalfunctionNov 15, 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 7036152 ↗
• InjuryOct 31, 2017Device Issue; Device Issue

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS AND ALLEGED ON (B)(6) 2017 THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 390MG/DL, WITH AN ALLEGED INACCURATE DELIVERY ISSUE. REPORTEDLY, THE PATIENT RECEIVED UNSPECIFIED TREATMENT IN THE EMERGENCY ROOM BY THEIR HEALTHCARE PROVIDER. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, THE PATIENT STATED THE PUMP WAS ¿GIVING TOO MUCH INSULIN¿. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT RECEIVED TREATMENT IN THE EMERGENCY ROOM ASSOCIATED WITH AN INACCURATE DELIVERY ISSUE.

  Patient problems: Hyperglycemia

  MAUDE report 6992469 ↗
• MalfunctionOct 26, 2017Structural Problem; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) 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 6982648 ↗
• InjuryOct 26, 2017Inaccurate Delivery; Inaccurate Delivery

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON (B)(6) 2017, THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) OF 22 MG/DL WITH DIFFICULTY SPEAKING, UNSTEADINESS WHEN STANDING AND WALKING, CONFUSION, COGNITIVE IMPAIRMENT AND SEVERE HEADACHE ASSOCIATED WITH AN ALLEGED INACCURATE DELIVERY ISSUE. REPORTEDLY, THE PATIENT REMAINED ON THE PUMP AND WAS TREATED BY THE EMTS WITH A GLUCAGON INJECTION AND INTRAVENOUS FLUIDS AND WAS THEN TAKEN TO THE HOSPITAL WHERE OTHER TREATMENTS WERE PERFORMED. THE PUMP WAS REMOVED FROM THE PATIENT WHEN THE PATIENT WAS AT THE HOSPITAL AND UPON DISCHARGE, THE PATIENT RESUMED PUMP THERAPY. THE REPORTER MENTIONED THAT THE PATIENT TOOK THEIR BG AT 7:10AM ON FRI(B)(6) 2017 AND IT WAS 147MG/DL AND DID A BG CORRECTION OFF PUMP CALCULATION. THE BG WAS 114MG/DL AT BREAKFAST AT 8:15AM. AND THE PATIENT DID AN EZ CARB CORRECTION. AROUND 10 AM, THE PATIENT WAS IN BED WITH FLU LIKE SYMPTOMS (VOMITING, FEVER AND CHILLS). THE PATIENT RECALLED BEING EXTREMELY WEAK AND TIRED AND HAVING A SEVERE HEADACHE. IT WAS NOTED THAT AT NOON, SHE WAS UNCONSCIOUS IN HER BED WHEN HER MOTHER CAME IN. WHEN THE PATIENT¿S BG WAS TAKEN, IT WAS FOUND TO BE AT 22 MG/DL. DURING TROUBLES

  Patient problems: Ambulation or Postural Difficulties; Dysphasia; Hypoglycemia

  MAUDE report 6979097 ↗
• MalfunctionOct 19, 2017Device Issue; Device Issue

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A OTHER (UNUSUAL ISSUE) ISSUE. IT WAS ALLEGED THE PATIENT "COULD NOT GET PAST THE VERIFY SCREEN". 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 6964059 ↗
• MalfunctionOct 6, 2017Failure to Prime; Failure to Prime

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT THE PUMP REPEATEDLY EMITTED LOSS OF PRIME WARNINGS DESPITE CARTRIDGE CHANGES. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS 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 6921764 ↗
• MalfunctionOct 2, 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 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 6907361 ↗
• MalfunctionSep 22, 2017Use of Device Problem; Use of Device Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT EXPERIENCED AN ELEVATED BLOOD GLUCOSE OVER 600 MG/DL WITH EXTREME DROWSINESS ASSOCIATED WITH AN ALLEGED TIME/DATE ISSUE. REPORTEDLY, THE PATIENT CONTINUED PUMP THERAPY AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THAT THE PUMP¿S TIME WAS WRONG BECAUSE THE PATIENT WAS INCORRECTLY SETTING THE TIME. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH AN ALLEGED TIME/DATE ISSUE, WITH USE ERROR AS A CONTRIBUTING FACTOR.

  Patient problems: Hyperglycemia; Lethargy

  MAUDE report 6886117 ↗
• MalfunctionSep 21, 2017Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem

  ON (B)(6), THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. IT WAS REPORTED THAT THE BATTERY CAP COULD NOT TIGHTEN ONTO THE BATTERY COMPARTMENT. THERE WAS NO INDICATION THAT THE PRODUCT 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 6885468 ↗
• MalfunctionSep 14, 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 6864981 ↗
• MalfunctionSep 12, 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. IT WAS REPORTED THAT THERE WAS A 069 CALL SERVICE ALARM. 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 6860824 ↗
• MalfunctionSep 12, 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 NOTED THAT THERE WAS MOISTURE FOUND WITHIN THE BATTERY COMPARTMENT. 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 6858336 ↗
• MalfunctionSep 7, 2017Structural Problem; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE) ISSUE. IT WAS NOTED THAT THE BATTERY CAP TOP WAS FOUND TO BE WORN. IT WAS ALSO NOTED THAT THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THERE IS NO INDICATION THAT THE PRODUCT ISSUE 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 6848085 ↗
• MalfunctionAug 30, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) 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 6833215 ↗
• MalfunctionAug 18, 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 WITH DAMAGE) ISSUE. IT WAS ALLEGED THAT THE TOP OF THE BATTERY CAP WAS WORN. 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 6803448 ↗
• MalfunctionAug 10, 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 6784945 ↗
• MalfunctionAug 8, 2017Image Display Error/Artifact; Image Display Error/Artifact

  THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE DISPLAY WAS DIM. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 07/18/2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6776010 ↗
• MalfunctionAug 7, 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 6769966 ↗
• MalfunctionAug 3, 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. THE REPORTER ALLEGED THE UP ARROW, DOWN ARROW, AND OK BUTTONS WERE UNDER RESPONSIVE. 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 6766156 ↗