Animas Vibe 11451500Recalls & reported problems

Summary

The FDA's MAUDE database contains 516 adverse event reports that list this exact device (DI 10840406100075), received between Aug 8, 2016 and Oct 21, 2019 — classified as 19 injuries, 495 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (188 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 516 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2019Structural 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 (B)(6) 2019. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9213137 ↗
• MalfunctionAug 28, 2019Structural 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 21-AUG-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8939343 ↗
• MalfunctionAug 20, 2019Structural Problem; Device Displays Incorrect Message; Fail-Safe Problem; Structural Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON 03-AUG-2019, THE REPORTER CONTACTED ANIMAS AND REPORTED THAT CALL SERVICE ALARM [069] HAD BEEN EMITTED BY THE PUMP MORE OFTEN THAN EXPECTED BY THE USER. 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 8911342 ↗
• MalfunctionJul 18, 2019Image Display Error/Artifact; Structural Problem; Image Display Error/Artifact; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A BATTERY COMPARTMENT CRACK AND A DIM/FADING COLOR SPECTRUM AND DAMAGED BATTERY CAP. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 16-JUL-2019

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8802617 ↗
• MalfunctionJul 10, 2019Defective Alarm; Defective Alarm

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A AUDIO TONE/VIBRATION (WEAK VIBRATION) 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 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 8777682 ↗
• MalfunctionJul 10, 2019Failure to Read Input Signal; Failure to Read Input Signal

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE; ALL KEYPAD BUTTONS UNRESPONSIVE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE CAN RESULT IN INADVERTENT OR INCORRECT INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8777423 ↗
• MalfunctionJul 10, 2019Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 078) 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 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 8776311 ↗
• MalfunctionJun 14, 2019Structural Problem; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION 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 13-JUN-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8699649 ↗
• MalfunctionMay 24, 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 22-MAY-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8639802 ↗
• MalfunctionMay 7, 2019Structural Problem; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DAMAGED CARTRIDGE COMPARTMENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10-MAY-2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8587255 ↗
• MalfunctionMay 6, 2019Pumping Problem; Pumping Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THE PUMP WAS NOT DELIVERING INSULIN CORRECTLY BECAUSE THEY "COULD NOT SEE INSULIN COMING OUT". THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE 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 8582168 ↗
• MalfunctionMay 6, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A MOTOR (MOTOR ISSUE) ISSUE. THE REPORTER ALLEGED THE PUMP WOULD REWIND ITSELF WITHOUT USER INPUT. THE REPORTER REFUSED TO TROUBLESHOOT THIS ALLEGED ISSUE WITH ANIMAS CUSTOMER SUPPORT. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE COULD CAUSE DELAY IN INSULIN DELIVERY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8581840 ↗
• MalfunctionJan 4, 2019Failure to Read Input Signal; Structural Problem; Failure to Read Input Signal; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGE PRIOR TO DAMAGE) ISSUE; KEYPAD PEELING OFF WITH MOISTURE INGRESS AND ALL KEYPAD BUTTON UNRESPONSIVE. THE REPORTER ALLEGED THE PUMP WAS PACKED AWAY IN NOVEMBER 2017 AND IS, AT THIS TIME, LOST. RETURN OF THE DEVICE FOR INVESTIGATION IS NOT EXPECTED DUE TO THE PUMP BEING LOST. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE CAN RESULT IN INADVERTENT OR INCORRECT INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8219106 ↗
• MalfunctionDec 11, 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 UP ARROW, DOWN ARROW AND OK BUTTONS ARE REPORTEDLY UNDER RESPONSIVE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE CAN RESULT IN INADVERTENT OR INCORRECT INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8151198 ↗
• MalfunctionDec 11, 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 8150814 ↗
• InjuryNov 14, 2018Use of Device Problem; Use of Device Problem

  ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT HAD BEEN HOSPITALIZED ON (B)(6) 2018. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE OVER 600 MG/DL WITH SYMPTOMS OF THIRST AND CHEST PAINS. THE PATIENT WAS TREATED AT THE HOSPITAL WITH INSULIN VIA INJECTION AND INTRAVENOUS FLUIDS. THE PATIENT WAS ON HEART DISEASE MEDICATIONS AT THE TIME AS WELL. THE REPORTER STATED THAT THE PUMP¿S TIME AND DATE SETTINGS WOULD RESET WHENEVER THE PUMP WAS REBOOTED. IF THE PATIENT DID NOT VERIFY THE CORRECT TIME AND DATE WHEN THE PUMP WAS POWERED ON, THE PUMP WOULD DELIVER A DIFFERENT BASAL RATE THAN WHAT THE PATIENT WOULD EXPECT. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT AS A RESULT OF USE ERROR OF THE DEVICE.

  Patient problems: Chest Pain; Hyperglycemia; Polydipsia

  MAUDE report 8068752 ↗
• MalfunctionNov 7, 2018Structural Problem; Structural Problem

  ON (B)(6) 2018, 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 8046481 ↗
• MalfunctionOct 12, 2018No Display/Image; Structural Problem; No Display/Image; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DAMAGED) ISSUE. IT WAS REPORTED THAT THE DISPLAY SCREEN WAS DETACHED FROM THE PUMP. 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 7960844 ↗
• MalfunctionSep 13, 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 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 7872835 ↗
• MalfunctionSep 12, 2018Electrical /Electronic Property Problem; Moisture Damage; Electrical /Electronic Property Problem; Moisture Damage

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER STATED THE PATIENT WORE THE PUMP WHILE SWIMMING TWO DAYS PRIOR TO THE REPORT DATE AND AFTERWARD, THE PUMP "STOPPED WORKING" AND THE REPORTER QUESTIONED THE WATERPROOF QUALITY OF THE PUMP BECAUSE MOISTURE WAS NOTED BEHIND THE DISPLAY SCREEN AT THE TIME OF THE POWER INTERRUPTION. THE REPORTER DENIED DAMAGE TO THE BATTERY COMPARTMENT AND THE BATTERY CAP. 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 7868528 ↗
• MalfunctionAug 27, 2018Premature Discharge of Battery; Premature Discharge of Battery

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE REPORTER WAS UNABLE TO PARTICIPATE IN TROUBLESHOOTING THE ISSUE WITH ANIMAS CUSTOMER SUPPORT DUE TO AN UNRELATED PUMP 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7819677 ↗
• MalfunctionAug 20, 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; CRACKED BATTERY COMPARTMENT WITH INTERMITTENT POWER ISSUE. THE REPORTER STATED THE BATTERY CAP HAD NEVER BEEN REPLACED ON THIS PUMP. 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 7797976 ↗
• MalfunctionJul 12, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property 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 399 MG/DL WITH SYMPTOMS OF CONFUSION AND DIZZINESS. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE NORMAL COURSE OF DIABETES MANAGEMENT. THE REPORTER STATED THAT THE PUMP LOST POWER OVERNIGHT WHILE THE PATIENT WAS SLEEPING, CAUSING THE BLOOD GLUCOSE EXCURSION. THE REPORTER NOTED THAT THERE WAS MOISTURE PRESENT IN THE PUMP. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT DUE TO THE PUMP LOSING POWER.

  Patient problems: Hyperglycemia

  MAUDE report 7681236 ↗
• MalfunctionJun 28, 2018Moisture Damage; Structural Problem; Moisture Damage; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE WITH MOISTURE) ISSUE. IT WAS ALLEGED THAT THE BATTERY COMPARTMENT WAS DAMAGED, THE TOP OF THE BATTERY CAP WAS WORN, AND THERE WAS MOISTURE 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 OR CARTRIDGE COMPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7645570 ↗
• MalfunctionJun 27, 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 7642150 ↗