Animas Vibe 11651500Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10840406100372), received between Oct 6, 2016 and May 7, 2019 — classified as 6 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (25 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 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2019Structural Problem; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED THE CARTRIDGE COMPARTMENT WAS DAMAGED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 29-NOV-2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8587253 ↗
• InjuryNov 27, 2018Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER CONTACTED ANIMAS ON (B)(6) 2018 ALLEGING THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY EVIDENCED BY BLOOD GLUCOSE MEASURING >600 MG/DL WITH LARGE URINARY KETONES, VOMITING, NAUSEA AND ABDOMINAL PAIN. THE PATIENT WAS REPORTEDLY HOSPITALIZED AND RECEIVED INSULIN VIA THE PUMP AND VIA INTRAVENOUS INSULIN DRIP. THE REPORTER ALLEGED AN INACCURATE DELIVERY ISSUE WITH THE PUMP. TROUBLESHOOTING OF THE DEVICE BY ANIMAS CUSTOMER SUPPORT REVEALED THAT BASAL DELIVERY TOTALS IN TOTAL DAILY DOSE MATCHED THE ACTIVE BASAL PROGRAM TOTAL AND BASAL HISTORY MATCHES THE ACTIVE BASAL PROGRAM SETTINGS INDICATING THE PUMP WAS DELIVERING ACCURATELY PER THE PATIENT¿S BASAL PROGRAM SETTINGS. DURING TROUBLESHOOTING, ANIMAS CUSTOMER SUPPORT BECAME AWARE THAT THE PATIENT WAS NOT RESPONDING TO AN ALARM IN A TIMELY MANNER AND THIS IS A POTENTIAL CAUSE OF THE PERCEIVED INACCURATE DELIVERY ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY ASSOCIATED WITH A TRAINING/MISUSE ISSUE; TROUBLESHOOTING DID NOT CONFIRM AN INACCURATE DELIVERY ISSUE WITH THE PUMP AND BASAL DELIVERIES WERE RECORDED AS PROGRAMMED.

  Patient problems: Abdominal Pain; Hyperglycemia; Nausea

  MAUDE report 8105365 ↗
• MalfunctionNov 20, 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 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 8089805 ↗
• MalfunctionSep 3, 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 CORROSION IN THE BATTERY COMPARTMENT AND DENIED DAMAGE TO THE PUMP AND 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 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 7840562 ↗
• MalfunctionAug 31, 2018Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER CONTACTED ANIMAS ON (B)(6) 2018 ALLEGING THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY EVIDENCED BY BLOOD GLUCOSE MEASURING 307 MG/DL WITH MODERATE KETONES PRESENT. THE PATIENT REPORTEDLY DID NOT RECEIVE ANY TREATMENT ABOVE OR BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. THE REPORTER ALLEGED THE PATIENT HAD BEEN PLACED ON A REPLACEMENT PUMP THE PRIOR EVENING. TROUBLESHOOTING COMPLETED BY ANIMAS CUSTOMER SUPPORT DISCOVERED THAT THE CUSTOMER HAD NOT PROGRAMMED THE REPLACEMENT PUMP WITH THE PROPER BASAL RATES AND RATE PER HOUR SETTINGS. ANIMAS CUSTOMER SUPPORT ASSISTED THE CUSTOMER IN PROGRAMMING THE REPLACEMENT PUMP WITH THE PROPER SETTINGS FROM THE PREVIOUS PUMP¿S PROGRAMMING DURING TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED SERIOUS INJURY ASSOCIATED WITH A TRAINING/MISUSE ISSUE. NO PUMP MALFUNCTION WAS DISCOVERED DURING TROUBLESHOOTING.

  Patient problems: Hyperglycemia

  MAUDE report 7836588 ↗
• MalfunctionAug 30, 2018Structural Problem; Structural Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7834307 ↗
• MalfunctionAug 27, 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. 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 7818346 ↗
• MalfunctionAug 27, 2018Electrical /Electronic Property Problem; Moisture Damage; Electrical /Electronic Property Problem; Moisture Damage

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE; INTERMITTENT POWER DUE TO BATTERY CAP NOT FITTING SECURELY TO 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 7818257 ↗
• InjuryAug 21, 2018Use of Device Problem; Use of Device Problem

  ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT HAD EXPERIENCED A HYPERGLYCEMIC EVENT WHILE ON THE PUMP. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 400 MG/DL WITH SYMPTOMS OF DEHYDRATION, NAUSEA, AND VOMITING. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE NORMAL COURSE OF DIABETES MANAGEMENT. THE REPORTER STATED THAT THE PUMP WAS NOT DELIVERING ACCURATELY. A REVIEW OF THE PUMP HISTORY SHOWED THAT THE BASAL DELIVERIES DID NOT MATCH THE ACTIVE BASAL RATES. THE PUMP WAS RETURNED TO ANIMAS AND INVESTIGATED. THE INVESTIGATION OF THE DEVICE DETERMINED THAT THE PUMP¿S BASAL PROGRAM WAS MANUALLY CHANGED BY THE PATIENT ON THE DATE OF THE EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING A HYPERGLYCEMIC EVENT AS A RESULT OF USE ERROR OF THE DEVICE.

  Patient problems: Hyperglycemia; Vomiting

  MAUDE report 7800713 ↗
• MalfunctionAug 20, 2018Pumping Problem; Pumping Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE; THE BASAL HISTORY ALLEGEDLY DOES NOT MATCH THE PROGRAMMED BASAL RATES. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE 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 7797911 ↗
• MalfunctionJul 30, 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 OK/ENTER BUTTON WAS 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 7730421 ↗
• MalfunctionJul 30, 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 7730418 ↗
• MalfunctionMay 30, 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. 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 7554316 ↗
• MalfunctionFeb 13, 2018Premature Discharge of Battery; Structural Problem; Premature Discharge of Battery; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP HAD SHORTER THAN EXPECTED BATTERY LIFE. 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 SERIOUS INJURY ASSOCIATED WITH THE COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7266073 ↗
• InjuryFeb 12, 2018Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) OF 385 MG/DL WITH CHEST PAIN, NAUSEA AND EXCESSIVE URINATION ASSOCIATED WITH AN ALLEGED POWER AND DAMAGE ISSUE WITH THE PUMP. REPORTEDLY, THE PUMP WAS RESUMED AFTER REPLACEMENT AND THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THAT THE BATTERY COMPARTMENT HAD STRIPPED THREADS, THE PATIENT WAS UNABLE TO TIGHTEN THE BATTERY CAP ONTO THE PUMP AND THERE WAS INTERMITTENT POWER IN THE PUMP. IT WAS REPORTED THAT THE PUMP WAS REBOOTING THROUGHOUT THE MIDDLE OF THE NIGHT. THE PATIENT WAS ADVISED TO USE ALTERNATE PLAN OF INSULIN DELIVERY AS PRESCRIBED BY THEIR HEALTHCARE PROVIDER UNTIL A NEW PUMP ARRIVES. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA BECAUSE OF AN INTERMITTENT POWER AND DAMAGE ISSUE WITH THE PUMP.

  Patient problems: Chest Pain; Hyperglycemia; Nausea

  MAUDE report 7265010 ↗
• InjuryJan 26, 2018Use of Device Problem; Use of Device Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON (B)(6) 2017, THE PATIENT INITIATED A 911/EMERGENCY PROTOCOL AND WAS HOSPITALIZED FOR AN ELEVATED BLOOD GLUCOSE (BG) OF 502 MG/DL WITH VOMITING ASSOCIATED WITH AN ALLEGED PRIME ISSUE. REPORTEDLY, THE PATIENT REMAINED HOSPITALIZED AND WAS TREATED BY A HEALTHCARE PROVIDER AND RECEIVED INTRAVENOUS (IV) FLUIDS AS TREATMENT. IT COULD NOT BE DETERMINED WHETHER OR NOT THE PATIENT CONTINUED PUMP THERAPY. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THAT THE PATIENT WAS NOT PRIMING THE PUMP PER INSTRUCTIONS FOR USE (IFU) WHICH LIKELY LED TO THE PERCEIVED PRIME ISSUE. THE REPORTER DID NOT KNOW THE TYPE OF INFUSION SET THAT WAS BEING USED WITH THE PUMP. THE REPORTER WAS ADVISED IF THEY WERE USING AN ANIMAS PRODUCT THEY WERE NOT USING THOSE INFUSION SET PER IFU AND ADVISED TO THEM TO PRIME THE TUBING UNTIL THEY SEE 4 TO 5 DROPS COME OUT OF THE END OF THE TUBING. IT WAS ALSO REPORTED THAT THE PATIENT WAS UNDER A LOT OF FAMILY STRESS AS WELL. IT WAS DETERMINED THAT THE PUMP WAS WORKING PROPERLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THERE WAS A BG EXCURSION REQUIRING MEDICAL INTERVENTION ASSOCIATED

  Patient problems: Hyperglycemia; Vomiting

  MAUDE report 7222996 ↗
• InjuryJan 26, 2018Use of Device Problem; Use of Device Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 502 MG/DL WITH VOMITING ASSOCIATED WITH AN ALLEGED HISTORY/SETTINGS ISSUE. REPORTEDLY, IT WAS UNKNOWN WHETHER OR NOT THE PATIENT CONTINUED WITH PUMP THERAPY OR DISCONTINUED. THE PATIENT WAS TREATED BY A HEALTH CARE PROVIDER AT THE HOSPITAL WITH INTRAVENOUS FLUIDS. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS NOTED THAT THE PUMP WAS WORKING AS IT SHOULD BUT THE PATIENT WAS NOT PRIMING THE PUMP. IT WAS NOTED THAT BASAL DELIVERY TOTALS IN THE TOTAL DAILY DOSE DID NOT MATCH DUE TO A CARTRIDGE CHANGE AND THE PRIME MENU BEING ACCESSED. ALL BOLUSES WERE RECORDED AS PROGRAMMED. IT WAS ALSO NOTED THAT THE PATIENT BOLUSED WITH DELAYED EATING AND THERE WAS A CHANGE IN STRESS LEVEL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH USER ERROR AND NOT A PUMP MALFUNCTION.

  Patient problems: Hyperglycemia; Vomiting

  MAUDE report 7221172 ↗
• MalfunctionJan 25, 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. 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 7219611 ↗
• MalfunctionJan 12, 2018Date/Time-Related Software Problem; Date/Time-Related Software 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 (B)(6) 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7185388 ↗
• MalfunctionJan 7, 2018Structural Problem; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACKED AND UNDER RESPONSIVE OK BUTTON. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 09-DEC-2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7170792 ↗
• MalfunctionNov 14, 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. 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 7028540 ↗
• MalfunctionNov 2, 2017Failure to Read Input Signal; Structural Problem; Failure to Read Input Signal; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGE PRIOR TO DAMAGE) ISSUE. THE REPORTER ALLEGED THE OK/ENTER BUTTON WAS UNDER RESPONSIVE. 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 6996913 ↗
• MalfunctionOct 19, 2017Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. IT WAS ALLEGED THAT THE BATTERY CAP WAS UNABLE TO BE TIGHTENED, THE YELLOW O-RING WAS VISIBLE, THE BATTERY COMPARTMENT WAS CRACKED, AND THERE WAS INTERMITTENT POWER. 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 6964078 ↗
• MalfunctionOct 4, 2017Premature Discharge of Battery; Moisture Damage; Structural Problem; Premature Discharge of Battery; Moisture Damage; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE WITH DAMAGE/MOIST) ISSUE. IT WAS NOTED THAT THE BATTERY COMPARTMENT WAS CRACKED WITH MOISTURE INGRESS. 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 6913375 ↗
• MalfunctionOct 4, 2017Electrical /Electronic Property Problem; Moisture Damage; Structural Problem; Electrical /Electronic Property Problem; Moisture Damage; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE WITH MOISTURE INGRESS) ISSUE. IT WAS NOTED THAT THERE WAS MOISTURE WITHIN THE BATTERY COMPARTMENT AND THAT THE BATTERY COMPARTMENT WAS CRACKED. 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 6913339 ↗