Animas Vibe 13920000 (UDI 10840406103137)Recalls & reported problems

Summary

The FDA's MAUDE database contains 294 adverse event reports that list this exact device (DI 10840406103137), received between May 25, 2017 and Jul 28, 2020 — classified as 17 injuries, 277 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (100 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 294 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2020Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS AND REPORTED THAT CALL SERVICE ALARM [064] 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 10334831 ↗
• MalfunctionApr 22, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS ALLEGING A POWER (NO POWER) ISSUE. 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 9985818 ↗
• MalfunctionFeb 12, 2020Premature Discharge of Battery; Moisture Damage; Premature Discharge of Battery; Moisture Damage

  ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS ALLEGING A POWER (BATTERY LIFE W/ MOISTURE) ISSUE. IT WAS NOTED THAT THERE WAS MOISTURE BEHIND THE DISPLAY AFTER SWIMMING WITH 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 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 9699458 ↗
• MalfunctionFeb 11, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS ALLEGING A POWER (INTERMITTENT POWER) ISSUE BUT REFUSED TO TROUBLESHOOT THE PUMP WITH CUSTOMER TECHNICAL SUPPORT. 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 9694066 ↗
• MalfunctionOct 22, 2019Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS AND REPORTED THAT CALL SERVICE ALARM [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 9221273 ↗
• MalfunctionOct 11, 2019Structural Problem; Structural Problem

  ON (B)(6) 2019 THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS REPORTED THAT THE BATTERY 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 POWER CIRCUIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9180278 ↗
• MalfunctionSep 6, 2019Failure to Read Input Signal; Failure to Read Input Signal

  ON 03-SEPT-2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE UP ARROW AND DOWN ARROW 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 8969817 ↗
• MalfunctionAug 28, 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 22-AUG-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 8941348 ↗
• MalfunctionAug 28, 2019Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem

  ON 08-AUG-2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. IT WAS ALLEGED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE PATIENT WAS UNABLE TO TIGHTEN THE BATTERY CAP TO THE PUMP. 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 8939201 ↗
• MalfunctionAug 23, 2019Image Display Error/Artifact; Moisture Damage; Image Display Error/Artifact; Moisture Damage

  ON 14-AUG-2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) 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 8924980 ↗
• MalfunctionAug 13, 2019Pumping Problem; Pumping Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. IT WAS REPORTED THAT THE USER ¿HAD SOME ISSUES WITH PUMP THAT CAUSED THEM TO REACH THE MAX LIMITS.¿ THE PATIENT DID NOT WANT TO DISCUSS ISSUE. THE PATIENT WANTED ASSISTANCE WITH CHANGING MAX LIMIT DUE TO TOTAL DAILY DOSE (TTD) WARNING. CUSTOMER TECHNICAL SUPPORT PROVIDED ASSISTANCE AND CONFIRMED WITH NO FURTHER ASSISTANCE NEEDED. 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 8887291 ↗
• MalfunctionAug 7, 2019Structural Problem; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS 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 CARTRIDGE COMPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8869779 ↗
• MalfunctionJul 24, 2019Structural Problem; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) 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 8821831 ↗
• MalfunctionJul 10, 2019Moisture Damage; Failure to Read Input Signal; Moisture Damage; Failure to Read Input Signal

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE; ALL KEYPAD BUTTONS UNRESPONSIVE WITH MOISTURE BEHIND THE DISPLAY AND IN 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 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 8777189 ↗
• MalfunctionJul 10, 2019Electrical /Electronic Property Problem; Moisture Damage; Electrical /Electronic Property Problem; Moisture Damage

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE; DO DAMAGE TO THE PUMP WITH MOISTURE IN THE BATTERY COMPARTMENT AND INTERMITTENT POWER LOSS. 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 8777058 ↗
• MalfunctionJul 10, 2019Electrical /Electronic Property Problem; Moisture Damage; Structural Problem; Electrical /Electronic Property Problem; Moisture Damage; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE WITH MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED THE BATTERY COMPARTMENT WAS CRACKED WITH MOISTURE IN THE BATTERY COMPARTMENT, THE ELECTRICAL CONTACTS ON THE BATTERY CAP WERE DAMAGED AND THE PUMP HAD AN INTERMITTENT POWER ISSUE. 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 8776334 ↗
• 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 8776309 ↗
• MalfunctionJul 9, 2019No Display/Image; Moisture Damage; No Display/Image; Moisture Damage

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE; MOISTURE BEHIND THE DISPLAY LENS AND IN 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 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 8771039 ↗
• MalfunctionJul 3, 2019Structural Problem; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; A 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 8760096 ↗
• InjuryJul 1, 2019Use of Device Problem; Use of Device Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT EXPERIENCED ON (B)(6)2019 A BLOOD GLUCOSE AS HIGH AS 400MG/DL, WITH NAUSEA, VOMITING, FEVER, SWEATING, TACHYCARDIA, HEADACHE, AND SYMPTOMS OF DEHYDRATION, ASSOCIATED WITH AN ALLEGED INACCURATE DELIVERY ISSUE. REPORTEDLY, THE PATIENT RESUMED TREATMENT WITH THE SAME PUMP, AND WAS TREATED IN THE HOSPITAL BY THEIR HEALTHCARE PROVIDER WITH INSULIN VIA INJECTION, AND INTRAVENOUS FLUIDS. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS REVEALED THE BASAL DELIVERY TOTALS IN TOTAL DAILY DOSE DID NOT MATCH DUE TO A SUSPEND, AN ACCESSED BASAL EDIT SCREEN, THE CUSTOMER MAKING CHANGES TO THE BASAL PROGRAM. THE CUSTOMER ALLEGEDLY MADE CHANGES TO THEIR BASAL PROGRAM AFTER THE BLOOD GLUCOSE EXCURSION. THE BASAL HISTORY MATCHED THE ACTIVE BASAL PROGRAM SETTINGS. THE BOLUS TOTALS MATCHED, AND ALL BOLUSES WERE RECORDED AS PROGRAMMED. THE PATIENT WAS REFERRED TO THEIR HEALTHCARE PROVIDER FOR DIABETES MANAGEMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED BLOOD GLUCOSE EXCURSION WAS RELATED TO A TRAINING/MISUSE ISSUE AND THE PATIENT WAS REFERRED TO THEIR HEALTHCARE PROVIDER FOR FURTHER DIABETES MANAGEMENT.

  Patient problems: Hyperglycemia; Nausea; Vomiting

  MAUDE report 8748129 ↗
• MalfunctionJun 28, 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 (B)(6) 2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8744234 ↗
• MalfunctionJun 27, 2019Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (SEGMENTS MISSING) ISSUE. THE REPORTER ALLEGED SMALL SECTION OF PIXELS MISSING ON DISPLAY; VERTICALLY ON THE RIGHT-HAND SIDE, TOP TO BOTTOM. THE REPORTER STATED THAT THE SCREEN WAS ABLE TO BE READ SAFELY AND DECLINED TO RETURN THE PUMP TO THE MANUFACTURER. 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 8738909 ↗
• MalfunctionJun 27, 2019Low Audible Alarm; Low Audible Alarm

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A AUDIO TONE/VIBRATION (QUIET SOUNDS) 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 8738896 ↗
• MalfunctionJun 24, 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 064) ISSUE AS WELL AS CALL SERVICE 078 ALARMS 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 8727066 ↗
• MalfunctionJun 17, 2019Structural Problem; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE) ISSUE; THE BATTERY CAP IS REPORTEDLY STUCK ON THE PUMP AND NOT ABLE TO BE REMOVED. 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 8705036 ↗