Animas Vibe 11551400Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 10840406100266), received between Aug 10, 2016 and Dec 27, 2019 — classified as 20 injuries, 111 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (24 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 131 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2019Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. IT WAS REPORTED THAT THE PUMP HAD INTERMITTENT POWER AND CRACKED BATTERY COMPARTMENT. THE BATTERY CAP WAS UNABLE TO BE TIGHTENED SECURELY. THE PATIENT¿S BLOOD GLUCOSE (BG) WAS REPORTED TO BE GREATER THAN 250 MG/DL BUT LESS THAN 500 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 PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THIS 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 9526031 ↗
• MalfunctionJul 11, 2019Image Display Error/Artifact; Structural Problem; Image Display Error/Artifact; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISPLAY ISSUE AND A CASE/CONDITION ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 03-JUL-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8780018 ↗
• InjuryApr 5, 2019Pumping Problem; Pumping Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) IN THE LOW TEENS ASSOCIATED WITH AN ALLEGED INACCURATE DELIVERY ISSUE. IT WAS UNKNOWN IF THE PATIENT REMAINED ON THE PUMP, BUT IT WAS REPORTED THAT EMERGENCY MEDICAL SERVICES WERE NOTIFIED. IT WAS ALSO UNKNOWN IF THE PATIENT RECEIVED ANY TREATMENT. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, THE REPORTER STATED THERE WERE SIX SEPARATE INCIDENTS BETWEEN (B)(6) AND (B)(6) 2018. THE REPORTER RECALLED THAT THERE WAS AN EPISODE THAT OCCURRED ON (B)(6) 2018 AND (B)(6) 2018. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 19 MG/DL AT ONE POINT BUT COULD NOT REMEMBER WHAT THE EXACT BG WAS FOR EACH EPISODE. CUSTOMER TECHNICAL SUPPORT (CTS) WAS UNABLE TO DETERMINE WHAT THE ISSUES WERE WITH THE PUMP. TROUBLESHOOTING COULD NOT BE COMPLETED AT THE TIME OF THE COMPLAINT. CTS MADE ATTEMPTS TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION AND TROUBLESHOOTING, WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA DUE TO ISSUES WITH THE PUMP. THE PUMP COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR.

  Patient problems: Hypoglycemia

  MAUDE report 8487839 ↗
• MalfunctionApr 3, 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 THAT COULD NOT BE CLEARED FROM THE PUMP AFTER THE PUMP HAD BEEN WORN WHILE SWIMMING. 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 8478761 ↗
• MalfunctionFeb 7, 2019Structural Problem; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE BATTERY COMPARTMENT WAS CRACKED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10-OCT-2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8318086 ↗
• MalfunctionSep 7, 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 7854607 ↗
• MalfunctionAug 20, 2018Image Display Error/Artifact; Moisture Damage; Image Display Error/Artifact; Moisture Damage

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (CLOUDY W/ MOISTURE) ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND INVESTIGATION COMPLETED 15-AUG-2018. ON INVESTIGATION, THE DISPLAY WAS CONFIRMED TO BE CLOUDY WITH MOISTURE IN THE DISPLAY. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY SCREEN WAS NOTED TO BE DIM/DISCOLORED. 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 7798145 ↗
• MalfunctionAug 17, 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 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 7792913 ↗
• MalfunctionAug 14, 2018Structural Problem; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; CRACK NEAR THE 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 7782356 ↗
• MalfunctionAug 1, 2018Date/Time-Related Software Problem; Date/Time-Related Software Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM/PINK DISPLAY. THIS REPORT IS MADE BASED ON THE RESULTS OF THE INVESTIGATION COMPLETED (B)(6) 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7739769 ↗
• MalfunctionJul 20, 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 ALLEGED MOISTURE WAS BEHIND THE DISPLAY. 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 7707371 ↗
• MalfunctionJul 18, 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, 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 7697706 ↗
• MalfunctionJul 17, 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 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 7693451 ↗
• MalfunctionJul 12, 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 064) ISSUE. THE REPORTER ALLEGED MOISTURE WAS 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 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 7682221 ↗
• MalfunctionJul 10, 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 7674677 ↗
• MalfunctionJul 10, 2018No Display/Image; Moisture Damage; No Display/Image; Moisture Damage

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (CLOUDY W/ 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 7673977 ↗
• MalfunctionJun 29, 2018Moisture Damage; Moisture Damage

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7651725 ↗
• MalfunctionJun 28, 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 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 7645088 ↗
• InjuryJun 12, 2018Use of Device Problem; Use of Device 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 354 MG/DL WITH SYMPTOMS OF VOMITING AND NAUSEA. THE REPORTER STATED THAT THE PATIENT WAS NOT PROPERLY PRIMING THE INFUSION SET PRIOR TO USE. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT DUE TO USE ERROR OF THE DEVICE.

  Patient problems: Hyperglycemia

  MAUDE report 7591699 ↗
• MalfunctionJun 8, 2018Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS AND REPORTED THAT CALL SERVICE ALARM [064 AND 078] 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 7581920 ↗
• MalfunctionMay 29, 2018Defective Alarm; Defective Alarm

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A AUDIO TONE/VIBRATION (INTERMITTENT VIBRATION) ISSUE; PUMP IS REPORTEDLY PULSATING. 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 7548869 ↗
• MalfunctionMar 16, 2018Moisture Damage; Structural Problem; Moisture Damage; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE W/MOIST) ISSUE. THE CARTRIDGE COMPARTMENT CAP WAS ALLEGED TO BE CRACKED/DAMAGED, WITH MOISTURE PRESENT IN THE PUMP. 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 7345200 ↗
• MalfunctionJan 16, 2018Partial Blockage; Device Displays Incorrect Message; Partial Blockage; Device Displays Incorrect Message

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A OCCLUSION (FREQUENT/PERSISTENT) ISSUE. THERE WAS NO INDICATION THAT THE DEVICE 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 7196042 ↗
• MalfunctionJan 12, 2018Structural 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 (B)(6) 2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7186242 ↗
• InjuryDec 28, 2017Use of Device Problem; Use of Device Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT EXPERIENCED AN ELEVATED BLOOD GLUCOSE OF 575 MG/DL WITH NAUSEA, SYMPTOMS OF DEHYDRATION (DIZZY, LIGHTHEADED) AND AN UNSPECIFIED LEVEL OF KETONES ASSOCIATED WITH AN ALLEGED SUSPEND ISSUE WITH THE PUMP. REPORTEDLY, THE PATIENT RESUMED WITH THE SAME PUMP AND SELF-TREATED WITH INSULIN VIA INJECTION TO LOWER THEIR BG LEVEL. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THAT THE PATIENT DID NOT COMPLETELY UNDERSTAND THE PUMP¿S SUSPEND FEATURE AND HOW TO RESUME IT CORRECTLY. IT WAS ALSO DISCOVERED THAT THE PATIENT HAD PREVIOUSLY SUSPENDED THE PUMP BY ACCIDENT. THE PATIENT WAS EDUCATED ON THE FEATURE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY ASSOCIATED WITH TRAINING/MISUSE; NO PUMP MALFUNCTION WAS INDICATED.

  Patient problems: Dehydration; Hyperglycemia; Nausea

  MAUDE report 7151217 ↗