Animas Vibe 11520400Recalls & reported problems

Summary

The FDA's MAUDE database contains 209 adverse event reports that list this exact device (DI 10840406100228), received between Aug 11, 2016 and Aug 27, 2019 — classified as 17 injuries, 192 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (50 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 209 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2019Image Display Error/Artifact; Image Display Error/Artifact

  ON 15-AUG-2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. THERE WAS NO INDICATION THAT THE DEVICE 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 8934369 ↗
• MalfunctionJun 10, 2019Structural Problem; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CASE/CONDITION ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06-JUN-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8682559 ↗
• MalfunctionFeb 7, 2019Structural Problem; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 24-OCT-2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8316995 ↗
• MalfunctionFeb 7, 2019Moisture Damage; Failure to Read Input Signal; Structural Problem; Moisture Damage; Failure to Read Input Signal; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED THAT THE KEYPAD WAS PEELING AT THE OK BUTTON, THE OK BUTTON WAS FOUND TO BE HYPERSENSITIVE TO BUTTON PRESSES. THERE WAS MOISTURE CORROSION OBSERVED UNDER THE OK BUTTON CONTACT. EVALUATION ALSO REVEALED A CRACK IN THE BATTERY COMPARTMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 04-FEB-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8314811 ↗
• MalfunctionFeb 7, 2019Structural Problem; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED CONTAMINATION UNDER THE ALL OF THE KEYPAD BUTTON CONTACTS. EVALUATION ALSO REVEALED CRACKS IN THE BATTERY COMPARTMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 01-FEB-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8314705 ↗
• InjuryDec 20, 2018Pumping Problem; Pumping Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 452 MG/DL WITH POLYDIPSIA AND SYMPTOMS OF DEHYDRATION ASSOCIATED WITH AN ALLEGED UNUSUAL ISSUE. REPORTEDLY, THE PATIENT REMAINED ON THE PUMP AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, THE REPORTER STATED THAT THEY THOUGHT THERE WAS A LOSS OF PRIME ALARM THAT WENT OFF BUT IT WAS NOT INDICATED ON THE SCREEN. THE REPORTER STATED THAT THIS ISSUE WAS AN INTERMITTENT ISSUE. UPON FURTHER TROUBLESHOOTING, THERE WERE NO ALARMS INDICATED IN THE ALARM HISTORY AND THE LOSS OF PRIME ALARM COULD NOT BE CERTAIN. THE REPORTER STATED THAT BECAUSE OF THIS ISSUE, THE PATIENT¿S BG WENT UP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA DUE TO AN UNKNOWN ALARM.

  Patient problems: Dehydration; Hyperglycemia; Polydipsia

  MAUDE report 8183955 ↗
• MalfunctionDec 10, 2018No Display/Image; No Display/Image

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) 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 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 8146872 ↗
• MalfunctionNov 20, 2018Moisture Damage; Structural Problem; Moisture Damage; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CASE DAMAGE W/MOISTURE) ISSUE; CRACKED BATTERY COMPARTMENT. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION CAN 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 8089178 ↗
• MalfunctionOct 2, 2018Moisture Damage; Failure to Read Input Signal; Moisture Damage; Failure to Read Input Signal

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. IT WAS REPORTED THAT THE UP ARROW, DOWN ARROW, AND OK/ENTER BUTTONS WERE UNDER-RESPONSIVE AND THAT MOISTURE WAS LOCATED BEHIND THE DISPLAY. 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 7926328 ↗
• MalfunctionSep 25, 2018Partial Blockage; Device Displays Incorrect Message; Partial Blockage; Device Displays Incorrect Message

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A OCCLUSION (FREQUENT/PERSISTENT) 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 7906678 ↗
• MalfunctionAug 31, 2018Moisture Damage; Structural Problem; Moisture Damage; Structural Problem

  THE REPORTER CONTACTED ANIMAS ON (B)(6) 2018 ALLEGING THERE WAS MOISTURE IN THE BATTERY COMPARTMENT WITH AN INTERMITTENT POWER ISSUE. THE REPORTER DENIED DAMAGE TO THE BATTERY COMPARTMENT AND BATTERY CAP. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND INVESTIGATION COMPLETED (B)(6) 2018. ON INVESTIGATION A REVIEW OF THE BLACK BOX DATA DID NOT REVEAL ANY RECORDS OF UNEXPLAINED POWER ON RESET EVENTS PRIOR TO THE COMPLAINT DATE. HOWEVER, MULTIPLE UNEXPLAINED POWER ON RESET EVENTS WERE OBSERVED IN THE BLACK BOX DATA AFTER THE COMPLAINT DATE, ON (B)(6) 2018. ON EXAMINATION, THE ¿COIN SLOT¿ ON THE TOP OF THE BATTERY CAP WAS NOTED TO BE WORN; THE BATTERY CAP WAS EVALUATED AND FOUND TO MEASURE WITHIN THE REQUIRED SPECIFICATIONS. THE BATTERY COMPARTMENT WAS NOTED TO BE CRACKED WITH EVIDENCE OF MOISTURE CONTAMINATION INSIDE THE BATTERY COMPARTMENT. THE RETURNED BATTERY CAP WAS UNABLE TO FULLY TIGHTEN TO THE PUMP AND AN INTERMITTENT POWER ISSUE WAS DUPLICATED. LEAK TESTING CONFIRMED MOISTURE INGRESS INTO THE BATTERY COMPARTMENT AT THE SITE OF THE BATTERY COMPARTMENT CRACK. THERE WAS NO DAMAGE, DEFECT OR CONTAMINATION OF THE INTERIOR PUMP COMPONENTS. THE PUMP WAS UNABLE TO BE EXERCISED ON A 1

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7836641 ↗
• MalfunctionAug 23, 2018Moisture Damage; Moisture Damage

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE. IT WAS ALLEGED THERE WAS MOISTURE BEHIND THE DISPLAY. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7811057 ↗
• MalfunctionAug 16, 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. 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 7789640 ↗
• InjuryAug 9, 2018Pumping Problem; Pumping Problem

  ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT HAD EXPERIENCED A HYPERGLYCEMIC EVENT WHILE ON THE PUMP. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 500 MG/DL WITH NO ASSOCIATED SYMPTOMS. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE NORMAL COURSE OF DIABETES MANAGEMENT. THE REPORTER ALLEGED THAT THERE WAS A DELIVERY ISSUE WITH THE PUMP, BUT WAS UNWILLING TO COMPLETE TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT DUE TO A PUMP MALFUNCTION.

  Patient problems: Hyperglycemia

  MAUDE report 7766829 ↗
• MalfunctionJul 18, 2018Failure 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 THAT THE 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 7698530 ↗
• MalfunctionJul 12, 2018Premature Discharge of Battery; Premature Discharge of Battery

  ON (B)(64) 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 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 7682166 ↗
• MalfunctionJul 6, 2018Moisture Damage; Temperature Problem; Moisture Damage; Temperature Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (TEMP ¿ MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED THE PUMP WAS HOT AND CONTAINED MOISTURE AFTER SWIMMING IN A HOT TUB. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT 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 7667123 ↗
• MalfunctionJun 28, 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. IT WAS NOTED THAT THE UP, DOWN AND OK BUTTONS WERE UNDER RESPONSIVE TO USER PRESSES. 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 7645070 ↗
• MalfunctionJun 19, 2018Moisture Damage; Moisture Damage

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE. IT WAS REPORTED THAT MOISTURE WAS LOCATED 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 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7613647 ↗
• MalfunctionJun 6, 2018Moisture Damage; Failure to Read Input Signal; Moisture Damage; Failure to Read Input Signal

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. IT WAS REPORTED THAT THE DOWN AND UP ARROW BUTTONS AND THE OKAY BUTTON 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 7573033 ↗
• MalfunctionJun 6, 2018Defective Alarm; Defective Alarm

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A AUDIO TONE/VIBRATION (VIBRATION ISSUE) ISSUE. IT WAS REPORTED THAT THE PUMP WAS PULSATING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED 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 7573032 ↗
• MalfunctionJun 5, 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 088) 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 7570818 ↗
• MalfunctionApr 25, 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. THE REPORTER ALLEGED THE BATTERY COMPARTMENT WAS DAMAGED, AND THE CAP WAS UNABLE TO BE SECURED. 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 7459297 ↗
• MalfunctionApr 21, 2018Structural Problem; Structural Problem

  ON (B)(6) 2018, 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 7449680 ↗
• MalfunctionApr 20, 2018Moisture Damage; Temperature Problem; Moisture Damage; Temperature Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (TEMP - MOISTURE INGRESS W/ DMG) ISSUE. THE REPORTER CLAIMED A TEMPERATURE ISSUE WITH THE PUMP; THE BATTERY COMPARTMENT IS DAMAGED WITH MOISTURE INGRESS. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT 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 7446267 ↗