Animas Vibe 11851400Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10840406100600), received between Nov 8, 2016 and Jun 12, 2019 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (4 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 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. THE REPORTER ALLEGED AN INTERMITTENT POWER ISSUE. THE REPORTER DENIED DAMAGE TO THE PUMP AND BATTERY CAP AND DENIES MOISTURE INSIDE 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 8691340 ↗
• MalfunctionJun 12, 2019Image Display Error/Artifact; Moisture Damage; Image Display Error/Artifact; Moisture Damage

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLORSPCTRM W/MOIST) ISSUE. THE REPORTER ALLEGED THERE WAS MOISTURE 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 8691170 ↗
• MalfunctionJun 12, 2019Premature Discharge of Battery; Moisture Damage; Premature Discharge of Battery; Moisture Damage

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ MOISTURE) ISSUE. THE REPORTER ALLEGED THE BATTERY LIFE WAS LESS THAN EXPECTED. THE REPORTER FURTHER STATED THERE WAS EVIDENCE OF MOISTURE IN THE BATTERY COMPARTMENT AND DENIED DAMAGE TO THE PUMP. TROUBLESHOOTING CONFIRMED LOW BATTERY WARNINGS 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 8690920 ↗
• MalfunctionAug 31, 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 7840456 ↗
• MalfunctionJun 15, 2018Temperature Problem; Temperature Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THERE WAS A TEMPERATURE ISSUE. 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. THERE WAS NO SERIOUS INJURY ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7604999 ↗
• MalfunctionJun 12, 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 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 7591638 ↗
• MalfunctionApr 21, 2018Structural Problem; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) 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 7449679 ↗
• MalfunctionApr 11, 2018Moisture Damage; Structural Problem; Moisture Damage; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CASE DAMAGE WITH MOISTURE) ISSUE. IT WAS ALLEGED THAT THE BATTERY COMPARTMENT WAS DAMAGED WITH MOISTURE IN IT. 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 7420835 ↗
• MalfunctionDec 18, 2017Partial 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 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 7124738 ↗
• MalfunctionNov 17, 2017Structural Problem; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE) ISSUE. IT WAS REPORTED THAT THE BATTERY CAP WAS UNABLE 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 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 7043633 ↗
• MalfunctionNov 7, 2017Defective Alarm; Defective Alarm

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A AUDIO TONE/VIBRATION (INTERMITTENT SOUND) ISSUE. IT WAS ALLEGED THAT THE VIBRATORY ALARM WAS WORKING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE 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 7008557 ↗
• InjuryOct 12, 2017Device Issue; Device Issue

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT DAY THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 452 MG/DL WITH MODERATE KETONES, ASSOCIATED WITH AN ALLEGED INACCURATE DELIVERY ISSUE. REPORTEDLY, THE PATIENT DISCONTINUED PUMP THERAPY AND RECEIVED TREATMENT OF PHONE ADVICE FROM THEIR HEALTHCARE PROVIDER. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS REVEALED THE BASAL HISTORY DID NOT BATCH THE ACTIVE BASAL PROGRAM. A REVIEW OF THE BASAL HISTORY SHOWED A ZERO UNIT BASAL. THE PUMP HISTORY WAS REVIEWED AND THE PUMP WAS NOT SUSPENDED, THE BASAL RATES WERE NOT EDITED, AND NO PRIMES WERE RECORDED. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH AN INACCURATE DELIVERY ISSUE.

  Patient problems: Hyperglycemia

  MAUDE report 6947051 ↗
• MalfunctionOct 9, 2017No Audible Alarm; No Audible Alarm

  ON (B)(6), THE REPORTER CONTACTED ANIMAS, ALLEGING A AUDIO TONE/VIBRATION (NO SOUNDS) ISSUE. IT WAS ALLEGED THAT THE VIBRATORY ALARM WAS WORKING. THERE WAS NO INDICATION THAT THE PRODUCT 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 6933636 ↗
• MalfunctionSep 6, 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 INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE 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 6847494 ↗
• MalfunctionJul 19, 2017Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 012) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6726569 ↗
• MalfunctionJul 19, 2017Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 012) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6726566 ↗
• MalfunctionJul 17, 2017Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 052/053/054/055 SLEEP) ISSUE. THERE WAS NO INDICATION THAT THIS ISSUE LEAD TO AN ADVERSE EVENT. THIS 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 6720510 ↗
• InjuryMay 3, 2017Excess Flow or Over-Infusion; Use of Device Problem; Excess Flow or Over-Infusion; Use of Device Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 40MG/DL WITH NO REPORTED SYMPTOMS ASSOCIATED WITH INADVERTENT INFUSION. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THE PATIENT WAS ATTACHED TO THE PUMP DURING THE PRIME STEP. THE REPORTER WAS NOT ABLE TO PROVIDE FURTHER INFORMATION DURING THE INITIAL COMPLAINT. CUSTOMER TECHNICAL SUPPORT 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 AS A RESULT OF USE ERROR.

  Patient problems: Hypoglycemia

  MAUDE report 6542929 ↗
• MalfunctionMay 1, 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 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 6535997 ↗
• MalfunctionMar 2, 2017No Display/Image; Structural Problem; No Display/Image; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DAMAGED) ISSUE. THE REPORTER ALLEGED THERE WERE SCRATCHES ON THE DISPLAY AND THEY WERE UNABLE TO READ IT. 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 6375238 ↗
• MalfunctionFeb 20, 2017Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THERE WAS A LINE THROUGH THE DISPLAY SCREEN. IT WAS REPORTED THAT THE USER¿S BLOOD GLUCOSE (BG) READING WAS GREATER THAN 250 MG/DL; HOWEVER, THE BG READING DID NOT EXCEED 500 MG/DL. NO SYMPTOMS OF HYPERGLYCEMIA WERE REPORTED. THE ALLEGED BG EXCURSION DOES NOT MEET ANIMAS CRITERIA FOR A SERIOUS INJURY AND IS THEREFORE NOT REPORTABLE AS 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 6344268 ↗
• InjuryNov 8, 2016Device Issue; Device Issue

  ON (B)(6) 2016, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT WHILE ON THE PUMP. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 35 MG/DL. THE PATIENT WAS REPORTEDLY TREATED WITH FOOD. THE REPORTER STATED THAT THE PUMP'S SETTINGS HAD BEEN INCORRECTLY PROGRAMMED. THE REPORTER WAS REFERRED TO THEIR HEALTHCARE PROVIDER FOR PROPERLY PROGRAMMING THE PUMP'S SETTINGS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT A PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT AS A RESULT OF INCORRECT PUMP SETTINGS.

  Patient problems: Hypoglycemia

  MAUDE report 6086131 ↗