Animas Vibe 11551000Recalls & reported problems

Summary

The FDA's MAUDE database contains 198 adverse event reports that list this exact device (DI 10840406100181), received between Aug 9, 2016 and Jul 14, 2020 — classified as 18 injuries, 180 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (58 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 198 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2020Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem

  ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. IT WAS REPORTED THAT THE PUMP HAD INTERMITTENT POWER AND 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 USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10273105 ↗
• MalfunctionAug 27, 2019Structural Problem; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED MULTIPLE CRACKS TO THE BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 20-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 8936229 ↗
• MalfunctionAug 7, 2019Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2019, 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 8870015 ↗
• MalfunctionMay 7, 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 31-AUG-2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8587512 ↗
• MalfunctionApr 9, 2019Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2019, 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 8495778 ↗
• MalfunctionFeb 14, 2019Structural Problem; Structural Problem

  ON (B)(6) 2019, 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 8338703 ↗
• MalfunctionFeb 7, 2019Structural Problem; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CASE/CONDITION. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 04-DEC-2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8317132 ↗
• 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 27-NOV-2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8317049 ↗
• MalfunctionDec 19, 2018Premature Discharge of Battery; Structural Problem; Premature Discharge of Battery; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ DAMAGE) 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 8178310 ↗
• MalfunctionOct 28, 2018Structural Problem; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; CRACKED BATTERY COMPARTMENT. THE REPORTER DENIED DAMAGE TO 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 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 8011274 ↗
• MalfunctionSep 14, 2018Premature Discharge of Battery; Moisture Damage; Premature Discharge of Battery; Moisture Damage

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ MOISTURE) ISSUE. THE REPORTER STATED THERE WAS MOISTURE IN THE BATTERY COMPARTMENT AND DENIED ANY DAMAGE TO THE BATTERY CAP OR BATTERY COMPARTMENT. 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 7876867 ↗
• MalfunctionSep 12, 2018Structural 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 10-SEP-2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7868004 ↗
• MalfunctionAug 30, 2018Structural Problem; Structural Problem

  THE REPORTER CONTACTED ANIMAS ON (B)(6) 2018 ALLEGING AN INTERMITTENT POWER ISSUE WITH THE PUMP BEGINNING (B)(6) 2018. THE REPORTER STATED THE THREADS IN THE BATTERY COMPARTMENT WERE STRIPPED. THE REPORTER DENIED ANY DAMAGE TO THE BATTERY CAP AND CONFIRMED THAT THE BATTERY CAP HAD NEVER BEEN REPLACED. 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 ON 27-AUG-2018. ON INVESTIGATION, THE BLACK BOX DATA REVEALED MULTIPLE UNEXPLAINED POWER ON RESET EVENTS RECORDED ON (B)(6) 2018. ON EXAMINATION, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AND THE RETURNED BATTERY CAP HAD STRIPPED THREADS. WITH THIS DAMAGED CAP IN PLACE ON THE PUMP, THE ALLEGED INTERMITTENT POWER ISSUE WAS DUPLICATED AS THE DAMAGED BATTERY CAP WAS UNABLE TO MAINTAIN ELECTRICAL CONNECTION. WITH A TEST BATTERY CAP IN PLACE ON THE PUMP, THE PUMP POWERED ON NORMALLY AND WAS ABLE TO COMPLETE EZ-PRIME STEPS WITHOUT POWER INTERRUPTION. THERE WAS NO DAMAGE, DEFECT OR CONTAMINATION OF THE PUMP¿S INTERIOR COMPONENTS. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY SCREEN WAS NOTED TO BE DIM/DISCOLORED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7834237 ↗
• MalfunctionJul 26, 2018Image Display Error/Artifact; Moisture Damage; Image Display Error/Artifact; Moisture Damage

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM WITH MOISTURE) ISSUE. IT WAS REPORTED THAT THE DISPLAY SCREEN LOOKED FUZZY 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 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 7721672 ↗
• MalfunctionJun 15, 2018Failure to Read Input Signal; Failure to Read Input Signal

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE KEYPAD BUTTONS WERE UNDER RESPONSIVE. 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. THERE WAS NO SERIOUS INJURY ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7604905 ↗
• InjuryJun 12, 2018Pumping Problem; Pumping Problem

  ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT HAD BEEN HOSPITALIZED IN 2017. THE REPORTER STATED THAT THE PATIENT HAD SLIPPED INTO A COMA AND WAS HOSPITALIZED FOR SEVERAL DAYS. THE REPORTER DID NOT PROVIDE A SPECIFIC BLOOD GLUCOSE AMOUNT BUT STATED THAT THE PATIENT HAD DIABETIC KETOACIDOSIS. THE REPORTER WAS UNABLE TO TROUBLESHOOT THE PUMP AT THE TIME OF THE CALL. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE ON THE PUMP.

  Patient problems: Hyperglycemia

  MAUDE report 7591458 ↗
• 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 [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 7582429 ↗
• 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 ALARMS [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 7581877 ↗
• MalfunctionMay 22, 2018Temperature Problem; Temperature Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (NO PHYSICAL DAMAGE) ISSUE. THE REPORTER ALLEGED THE PUMP WAS HOT TO THE TOUCH. 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 7534559 ↗
• MalfunctionMay 8, 2018No Display/Image; No Display/Image

  ON (B)(6) 2018, 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 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 7495081 ↗
• MalfunctionApr 17, 2018Moisture Damage; Moisture Damage

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED MOISTURE WAS PRESENT 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 7435886 ↗
• MalfunctionMar 28, 2018No Display/Image; No Display/Image

  ON (B)(6) 2018, 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 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 7378766 ↗
• MalfunctionMar 28, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER ALLEGED THE PUMP KEPT CYCLING THROUGH THE STARTUP PROCESS AND NEVER WENT TO THE VERIFY SCREEN. 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 7378494 ↗
• MalfunctionMar 27, 2018Structural Problem; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE) ISSUE. THE CARTRIDGE COMPARTMENT WAS ALLEGED TO BE CRACKED/DAMAGED. THE CARTRIDGE CAP WAS ALLEGED TO BE UNABLE TO BE REMOVED, AND TO HAVE STRIPPED THREADS. 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 7374251 ↗
• MalfunctionMar 27, 2018Structural Problem; Structural Problem

  ON (B)(6) 2018, 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 7374249 ↗