Animas Vibe 11520500Recalls & reported problems

Summary

The FDA's MAUDE database contains 206 adverse event reports that list this exact device (DI 10840406100235), received between Aug 12, 2016 and Nov 13, 2019 — classified as 18 injuries, 188 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 206 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 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 9317227 ↗
• MalfunctionMay 2, 2019Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING HE PUMP HAD NO POWER. THE REPORTER STATED THE BATTERY COMPARTMENT WAS CRACKED AND THE YELLOW O-RING OF THE BATTERY CAP WAS VISIBLE WITH THE CAP SECURED TO THE PUMP. THE REPORTER DENIED DAMAGE TO THE BATTERY CAP. THE REPORTER WAS UNABLE/UNWILLING TO PROVIDE INFORMATION REGARDING WHEN THE BATTERY CAP HAD LAST BEEN REPLACED ON THIS PUMP. THE REPORTER DENIED MOISTURE IN THE 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 8574527 ↗
• MalfunctionApr 15, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER DENIED DAMAGE TO THE PUMP OR THE BATTERY CAP AND STATED THE BATTERY CAP WAS ABLE TO SECURE TO THE PUMP PER THE INSTRUCTIONS FOR USE. 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 8514650 ↗
• 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 05-DEC-2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8317041 ↗
• MalfunctionDec 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 OK BUTTON IS REPORTEDLY NOT WORKING PROPERLY. 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 8170546 ↗
• MalfunctionNov 6, 2018Retraction Problem; Retraction Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A MOTOR (REWIND ISSUE) ISSUE. IT WAS REPORTED THAT THE PISTON ROD WAS NOT RETRACTING. 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 8041226 ↗
• MalfunctionOct 30, 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 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 8018388 ↗
• MalfunctionSep 14, 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; ALL KEYPAD BUTTONS ARE 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 7877263 ↗
• InjurySep 11, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE REPORTER CONTACTED ANIMAS ON (B)(6) 2018 ALLEGING THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY EVIDENCED BY BLOOD GLUCOSE MEASURING 507 MG/DL. THE PATIENT REPORTEDLY DID NOT HAVE A BACKUP PLAN FOR INSULIN DELIVERY. ANIMAS CUSTOMER SUPPORT ADVISED THE PATIENT TO CONTACT THEIR HEALTH CARE PROVIDER TO OBTAIN A BACKUP PLAN FOR TREATMENT OF THE HYPERGLYCEMIA. THE REPORTER ALLEGED THAT THE PUMP HAD BEEN WITHOUT POWER ALL DAY ON (B)(6) 2018; THE DISPLAY SCREEN WAS BLANK AND AFTER REBOOTING THE PUMP WITH A NEW BATTERY, THERE WAS NO POWER TO THE PUMP ALL DAY. THE REPORTER DENIED DAMAGE TO THE PUMP OR THE BATTERY CAP AND DENIED MOISTURE IN THE PUMP. THE REPORTER CONFIRMED THAT THE BATTERY CAP COULD BE SECURED TO THE PUMP PER THE INSTRUCTIONS FOR USE. THE REPORTER CONFIRMED THE CORRECT BATTERY TYPE WAS BEING USED IN THE PUMP AND THE POWER ISSUE OCCURRED IMMEDIATELY AFTER THE BATTERY WAS CHANGED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY ASSOCIATED WITH AN ISSUE OF NO POWER TO THE PUMP.

  Patient problems: Hyperglycemia

  MAUDE report 7863707 ↗
• MalfunctionSep 6, 2018Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2018 A REPORTER CONTACTED ANIMAS ALLEGING THAT THE PUMP HAD A CALL SERVICE 078 ALARM. 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. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7850202 ↗
• MalfunctionAug 31, 2018Structural Problem; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; CRACKED CARTRIDGE 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 7838437 ↗
• MalfunctionAug 31, 2018Premature Discharge of Battery; Premature Discharge of Battery

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE; THE BATTERY LIFE REPORTEDLY LASTS NO LONGER THAN THREE DAYS. 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 7836669 ↗
• MalfunctionAug 29, 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. IT WAS REPORTED THAT THE PUMP HAD NO POWER; THE BATTERY CAP WAS NOT ABLE TO BE REMOVED FROM THE PUMP. 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 7828411 ↗
• InjuryAug 14, 2018Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS AND ALLEGED ON (B)(6) 2018 THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 417MG/DL, WITH NAUSEA, POLYDIPSIA, AND POLYURIA, ASSOCIATED WITH AN ALLEGED POWER DAMAGE ISSUE. REPORTEDLY, THE PATIENT DISCONTINUED PUMP THERAPY AND RESUMED AFTER REPLACEMENT. THE PATIENT WAS TREATED IN THE EMERGENCY ROOM BY THEIR HEALTHCARE PROVIDER WITH INSULIN VIA INJECTION. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS REVEALED THE BATTERY COMPARTMENT WAS CRACKED, AND THERE WAS NO POWER TO THE PUMP. THE PATIENT ALLEGEDLY USED DIFFERENT BATTERIES WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH A NO POWER ISSUE.

  Patient problems: Hyperglycemia; Nausea; Polydipsia

  MAUDE report 7780394 ↗
• MalfunctionAug 6, 2018Structural Problem; Structural Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7753851 ↗
• MalfunctionJul 27, 2018Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLORSPCTRM W/MOIST) 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 7728178 ↗
• MalfunctionJul 6, 2018Date/Time-Related Software Problem; Date/Time-Related Software Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE TIME AND DATE RESET WHEN THE BATTERY WAS REMOVED FROM THE PUMP FOR LESS THAN 12 HOURS. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING RULED OUT BASED ON THE FOLLOWING: THIS ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE PUMP DISPLAYS THE VERIFY SCREEN AFTER IT IS REBOOTED AND THE TIME AND DATE MUST BE SET TO CONFIRM THE VERIFY SCREEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7667006 ↗
• InjuryMay 30, 2018Use of Device Problem; Use of Device Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT EXPERIENCED A LOW BLOOD GLUCOSE ASSOCIATED WITH AN ALLEGED ENVIRONMENTAL EXPOSURE ISSUE. REPORTEDLY, IT IS UNKNOWN IF THE PATIENT DISCONTINUED PUMP THERAPY. THE PATIENT WAS TREATED BY EMERGENCY MEDICAL SERVICES. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS REPORTED THAT THE PATIENT HAD AN IN BODY, BODY SCAN AND THE HEALTH CARE FACILITY DID NOT TELL THE PATIENT TO TAKE THE PUMP OFF. AFTER THE PROCEDURE, THE PUMP KEPT BEEPING AND THE PUMP GAVE THE PATIENT TOO MUCH INSULIN. THE PUMP WAS NOT AVAILABLE AT THE TIME TO TROUBLESHOOT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPOGLYCEMIA ASSOCIATED WITH USER ERROR.

  Patient problems: Hypoglycemia

  MAUDE report 7552809 ↗
• MalfunctionMay 21, 2018Moisture Damage; Structural Problem; Moisture Damage; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CASE DAMAGE W/MOISTURE) ISSUE. THE BATTERY COMPARTMENT WAS ALLEGED TO BE CRACKED/DAMAGED WITH MOISTURE PRESENT. 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 7530675 ↗
• MalfunctionMay 8, 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 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 7495077 ↗
• 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 7495076 ↗
• MalfunctionMay 4, 2018Inaccurate Delivery; Inaccurate Delivery

  THE REPORTER CONTACTED ANIMAS ON (B)(6) 2018 ALLEGING THE PUMP WAS FELT TO NOT BE DELIVERING INSULIN PROPERLY FOR THE PAST TWO WEEKS. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE REPORTER WAS UNWILLING TO PARTICIPATE IN TROUBLESHOOTING ACTIVITIES WITH ANIMAS CUSTOMER SUPPORT. THIS COMPLAINT IS BEING REPORTED BECAUSE THERE IS AN ALLEGATION AGAINST THE DELIVERY FUNCTION OF THE PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7486142 ↗
• MalfunctionMar 27, 2018Moisture Damage; Structural Problem; Moisture Damage; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CASE DAMAGE W/MOISTURE) ISSUE. THE BATTERY COMPARTMENT WAS ALLEGED TO BE CRACKED/DAMAGED WITH MOISTURE LOCATED INSIDE THE 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 7374301 ↗
• MalfunctionMar 22, 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. THE REPORTER ALLEGED THE BATTERY COMPARTMENT WAS CRACKED, AND THE TOP OF THE BATTERY CAP WORN. 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 7361126 ↗
• MalfunctionMar 16, 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 7345157 ↗