Animas Vibe 11620100Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10840406100297), received between Jan 19, 2017 and Feb 6, 2019 — classified as 1 injury, 45 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (12 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 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 24-JAN-2019

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8312017 ↗
• MalfunctionDec 11, 2018Structural Problem; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE) ISSUE; THE BATTERY CAP IS NOT ABLE TO BE REMOVED FROM THE PUMP. 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 8150739 ↗
• MalfunctionSep 7, 2018Structural Problem; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS ALLEGED THAT THE CARTRIDGE COMPARTMENT WAS 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 OR CARTRIDGE COMPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7854816 ↗
• MalfunctionSep 7, 2018Structural Problem; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS ALLEGED THAT THE BATTERY COMPARTMENT WAS 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 OR CARTRIDGE COMPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7854773 ↗
• MalfunctionAug 22, 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 AND UP BUTTON 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 7804370 ↗
• MalfunctionAug 14, 2018Premature Discharge of Battery; Premature Discharge of Battery

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. THE REPORTER ALLEGES BATTERY LIFE IS LESS THAN EXPECTED. LOW BATTERY ALARMS DO APPEAR IN THE ALARM HISTORY. 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 7782002 ↗
• MalfunctionAug 7, 2018Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  THE REPORTER CONTACTED ANIMAS ON (B)(6) 2018 ALLEGING A CALL SERVICE 064 ALARM ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. TROUBLESHOOTING COULD NOT BE COMPLETED AT THE TIME THE COMPLAINT WAS RECEIVED. ANIMAS CUSTOMER SUPPORT MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER TO COMPLETE TROUBLESHOOTING; HOWEVER, THE REPORTER DID NOT RESPOND. 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 7759035 ↗
• MalfunctionMay 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. THE REPORTER ALLEGED THAT THE UP, DOWN, AND 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 7523115 ↗
• MalfunctionJan 5, 2018Date/Time-Related Software Problem; Date/Time-Related Software Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (TIME LOSS/GAIN) ISSUE. IT WAS ALLEGED THAT THE PUMP WAS OFF BY FIVE MINUTES PER MONTH. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE IS BEING REPORTED TIME LOSS OR GAIN DURING USE, WITHOUT USER INTERVENTION, MAY RESULT IN THE USER RUNNING THE INCORRECT BASAL SEGMENT LEADING TO OVER OR UNDER DELIVERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7168121 ↗
• MalfunctionNov 8, 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 7012385 ↗
• MalfunctionNov 8, 2017Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2017, 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 7012378 ↗
• MalfunctionNov 8, 2017No Display/Image; No Display/Image

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DISPLAY ISSUE) ISSUE. IT WAS REPORTED THAT THE DISPLAY SCREEN BECAME WHITE. 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 7012377 ↗
• MalfunctionNov 8, 2017Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (LINE THROUGH DISPLAY) 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 7009477 ↗
• MalfunctionNov 7, 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 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 7008556 ↗
• MalfunctionOct 30, 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 6986309 ↗
• MalfunctionOct 26, 2017Structural Problem; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS REPORTED THAT THE CARTRIDGE 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 CARTRIDGE COMPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6982505 ↗
• MalfunctionOct 25, 2017No Display/Image; Moisture Damage; Structural Problem; No Display/Image; Moisture Damage; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DAMAGED W/ MOISTURE) ISSUE. IT WAS NOTED THAT THE DISPLAY SCREEN WAS DAMAGED AND THERE WAS MOISTURE BEHIND THE DISPLAY. 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 6976192 ↗
• MalfunctionOct 16, 2017Image Display Error/Artifact; Moisture Damage; Image Display Error/Artifact; Moisture Damage

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A LINE THROUGH THE DISPLAY WITH MOISTURE 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 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 6951737 ↗
• MalfunctionOct 11, 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 6943219 ↗
• MalfunctionOct 10, 2017Structural Problem; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. THE BATTERY COMPARTMENT WAS ALLEGED TO BE 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 6938246 ↗
• MalfunctionOct 4, 2017Premature Discharge of Battery; Premature Discharge of Battery

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) 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 6913489 ↗
• MalfunctionSep 28, 2017No Display/Image; No Display/Image

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE DISPLAY SCREEN WAS BLANK. 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 THE INABILITY TO USE THE PRODUCT WHICH MAY LEAD TO LONG TERM CESSATION OF DELIVERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6901908 ↗
• InjuryAug 31, 2017Partial Blockage; Device Displays Incorrect Message; Partial Blockage; Device Displays Incorrect Message

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT EXPERIENCED A BLOOD GLUCOSE GREATER THAN 250MG/DL BUT LESS THAN 500MG/DL WITH POLYURIA, POLYDIPSIA, AND EXTREME DROWSINESS, ASSOCIATED WITH AN ALLEGED OCCLUSION ISSUE. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS REVEALED THAT THE PATIENT DID NOT PRIME WHILE ATTACHED FOLLOWING THE OCCLUSION ALARM. THE CUSTOMER WAS UNABLE/UNWILLING TO TROUBLESHOOT INSULIN BEING PUSHED THROUGH THE CARTRIDGE AND THE TUBING. O THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH AN OCCLUSION ISSUE.

  Patient problems: Hyperglycemia; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 6837163 ↗
• MalfunctionAug 22, 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 BEHIND THE DISPLAY. 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 6812569 ↗
• MalfunctionAug 18, 2017Structural Problem; Structural Problem

  ON (B)(6) 2017, 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 6805109 ↗