OneTouch Ping 10543500Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10840406101010), received between Jan 13, 2017 and Apr 24, 2020 — classified as 20 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 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 YELLOW O-RING OF THE BATTERY CAP WAS VISIBLE AND THAT THE PUMP HAD NO POWER. 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 9997813 ↗
• MalfunctionNov 4, 2019Premature Discharge of Battery; Premature Discharge of Battery

  ON (B)(6) 2018, 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 9273535 ↗
• MalfunctionOct 22, 2019Premature Discharge of Battery; Structural Problem; Premature Discharge of Battery; Structural Problem

  ON (B)(6) 2918, 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 9218561 ↗
• MalfunctionOct 22, 2019Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem

  ON (B)(6) 2019, 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 9218535 ↗
• MalfunctionOct 10, 2019Device Displays Incorrect Message; Communication or Transmission Problem; Fail-Safe Problem; Device Displays Incorrect Message; Communication or Transmission Problem; Fail-Safe Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (COMMUNICATION) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED 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 9175483 ↗
• MalfunctionOct 9, 2019Structural Problem; Structural Problem

  ON (B)(6) 2019, 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. 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 9171469 ↗
• MalfunctionOct 4, 2019Image 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 9155550 ↗
• MalfunctionOct 2, 2019Image Display Error/Artifact; Image Display Error/Artifact

  ON 04-OCT-2016, 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 9145727 ↗
• MalfunctionOct 2, 2019Structural 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 09-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 9144733 ↗
• MalfunctionSep 27, 2019Electrical /Electronic Property Problem; Moisture Damage; Electrical /Electronic Property Problem; Moisture Damage

  ON 13-JUL-2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. 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 9130046 ↗
• MalfunctionSep 26, 2019Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON 01-AUG-2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 078) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THIS 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 9125609 ↗
• MalfunctionSep 23, 2019Moisture Damage; Structural Problem; Moisture Damage; Structural Problem

  ON 17-SEPT-2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CASE DAMAGE WITH MOISTURE) ISSUE. IT WAS ALLEGED THAT THE BATTERY COMPARTMENT WAS DAMAGED AND THAT THERE WAS MOISTURE IN 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 9103734 ↗
• InjuryNov 5, 2018Inaccurate Delivery; Inaccurate Delivery

  THE REPORTER CONTACTED ANIMAS ON (B)(6) 2018 ALLEGING THE PATIENT EXPERIENCED HYPOGLYCEMIA WHILE ON INSULIN PUMP THERAPY EVIDENCED BY BLOOD GLUCOSE MEASURING 40 MG/DL ACCOMPANIED BY UNSTEADINESS WHEN STANDING AND WALKING AND SEVERE HEADACHE. THE PATIENT REPORTEDLY DID NOT RECEIVE ANY TREATMENT ABOVE OR BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. THE REPORTER DID NOT PROVIDE ANY INFORMATION REGARDING TREATMENT OF THE HYPOGLYCEMIA. THE REPORTER ALLEGED THE PUMP WAS DELIVERING MORE INSULIN THAT IT WAS PROGRAMMED TO DELIVER TO THE PATIENT. THE REPORTER DID NOT COMPLETE TROUBLESHOOTING OF THE PUMP WITH ANIMAS CUSTOMER SUPPORT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY ASSOCIATED WITH AN ALLEGED INACCURATE INSULIN DELIVERY ISSUE.

  Patient problems: Ambulation or Postural Difficulties; Headache; Hypoglycemia

  MAUDE report 8037607 ↗
• InjurySep 4, 2018Pumping Problem; Pumping 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 OVER 600 MG/DL WITH SYMPTOMS OF DEHYDRATION, DIZZINESS, VOMITING, AND DIABETIC KETOACIDOSIS. THE PATIENT WAS TAKEN TO A HOSPITAL WHERE THEY WERE TREATED WITH INTRAVENOUS INSULIN. THE REPORTER BELIEVED THAT THE PUMP HAD NOT BEEN DELIVERING ACCURATELY. TROUBLESHOOTING COULD NOT BE APPROPRIATELY PERFORMED AT THE TIME OF THE CALL TO CONFIRM THIS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE ON THE PUMP AND THE PUMP COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Vomiting

  MAUDE report 7841954 ↗
• InjuryJul 19, 2018Inaccurate Delivery; Inaccurate Delivery

  ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT HAD EXPERIENCED A HYPOGLYCEMIC EVENT WHILE ON THE PUMP. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 21 MG/DL WITH SYMPTOMS OF CONFUSION AND COGNITIVE IMPAIRMENT. THE PATIENT WAS TAKEN TO AN EMERGENCY ROOM WHERE THEY WERE TREATED WITH INTRAVENOUS GLUCOSE AND FOOD/DRINK. THE REPORTER STATED THAT THE PATIENT HAD DISCONTINUED USE OF THE PUMP AT THE TIME OF THE CALL. THE REPORTER NOTED THAT THERE WAS A BOLUS DELIVERY AT 1 PM THAT THE PATIENT DID NOT BELIEVE WAS DELIVERED BY THEM. THE REPORTER STATED THAT THE PATIENT WAS AT A DOCTOR¿S OFFICE AT THE TIME OF THE UNEXPECTED DELIVERY, BUT THAT THE PATIENT HAD NOT TOUCHED THEIR PUMP SINCE 8 AM THAT MORNING. THE REPORTER ALLEGED THAT THE INSULIN HAD BEEN PROGRAMMED FOR DELIVERY BY A THIRD PARTY. THE REPORTER WAS UNABLE TO TROUBLESHOOT THE SOURCE OF THE EXTRA DELIVERY AT THE TIME OF THE CALL. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT WHILE ON THE PUMP DUE TO AN UNEXPECTED DELIVERY OF INSULIN.

  Patient problems: Confusion/ Disorientation; Hypoglycemia

  MAUDE report 7703648 ↗
• InjuryJul 17, 2018Date/Time-Related Software Problem; Date/Time-Related Software 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 OVER 500 MG/DL BUT THE REPORTER WAS UNABLE TO PROVIDE A SPECIFIC BLOOD GLUCOSE LEVEL OR SYMPTOMS THE PATIENT WAS EXPERIENCING. THE PATIENT WAS IN AN OUTPATIENT CLINIC AT THE TIME OF THE ALLEGED BLOOD GLUCOSE EXCURSION, BUT THERE WAS NO INFORMATION PROVIDED AS TO THE REASON FOR THE VISIT. THE REPORTER REVIEWED THE PUMP AND NOTICED THAT THE TIME SETTING WAS OFF FOR THE PUMP. THERE WAS NO KNOWN CAUSE FOR THE TIME DIFFERENCE. 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 7693461 ↗
• MalfunctionJul 12, 2018Pumping Problem; Pumping Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A OTHER (UNUSUAL ISSUE) ISSUE. THE REPORTER ALLEGED A 2355 ERROR APPEARED AFTER THE PUMP FELL ON THE FLOOR. THE ERROR ALLEGEDLY CONTINUED TO REAPPEARED AFTER MULTIPLE BATTERY CHANGES IN EFFORTS TO CLEAR THE ERROR. 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 ERROR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7682277 ↗
• InjuryApr 12, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT EXPERIENCED AN ELEVATED BLOOD GLUCOSE ABOVE 500 MG/DL WITH NO REPORTED ADDITIONAL SYMPTOMS ASSOCIATED WITH THE PUMP HAVING AN ALLEGED NO POWER ISSUE. REPORTEDLY, THE PATIENT CONTINUED PUMP THERAPY AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS) COULD NOT BE COMPLETED BECAUSE THE PATIENT DECLINED. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA AND THE PUMP COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR.

  Patient problems: Hyperglycemia

  MAUDE report 7426838 ↗
• InjuryMar 14, 2018Inaccurate Delivery; Inaccurate Delivery

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT EXPERIENCED LOW BLOOD GLUCOSE (BG) OF 44 MG/DL WITH A SEVERE HEADACHE, A STOMACH ACHE, SHAKINESS AND UNSTEADINESS WHEN STANDING AND WALKING ASSOCIATED WITH AN ALLEGED INACCURATE DELIVERY. REPORTEDLY, THE PATIENT DISCONTINUED PUMP THERAPY AND 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 BASAL DELIVERY TOTALS IN THE TOTAL DAILY DOSE MATCHED AS PROGRAMMED AND THE BASAL HISTORY MATCHED THE ACTIVE BASAL PROGRAM SETTINGS. TROUBLESHOOTING INDICATED ALL BOLUS SETTINGS AND HISTORIES WERE CORRECT AND THE PUMP WAS CALCULATING BOLUS DOSAGES CORRECTLY. TROUBLESHOOTING ALSO INDICATED THE FOLLOWING DIABETES MANAGEMENT FACTORS CONTRIBUTED TO THE ALLEGED BG EXCURSION: A RECENT SEVERE HYPOGLYCEMIA. THE REPORTED ALLEGED THAT THE PUMP¿S DELIVERY OF INSULIN WAS NOT ACCURATE SINCE AROUND 40 UNITS OF INSULIN SEEMINGLY DISAPPEARED. THERE WERE NO DEFECTS FOUND WITH THE PUMP BUT IT IS BEING REPLACED BECAUSE OF INSISTENCE FROM A HEALTHCARE PROVIDER WHO BELIEVES THE PUMP IS UNSAFE. THIS COMPLAINT I

  Patient problems: Headache; Hypoglycemia; No Code Available

  MAUDE report 7339789 ↗
• InjuryMar 6, 2018Use of Device Problem; Use of Device Problem

  ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE ON THE PUMP. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 362 MG/DL WITH SYMPTOMS OF THIRST, URINATION, AND DROWSINESS. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE NORMAL COURSE OF DIABETES MANAGEMENT. THE REPORTER STATED THAT THE PATIENT FORGOT TO PRIME THE PUMP WHILE USING IT, CAUSING A DELAY IN INSULIN DELIVERY. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT AS A RESULT OF USE ERROR OF THE DEVICE.

  Patient problems: Hyperglycemia

  MAUDE report 7316728 ↗
• InjuryJan 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT¿S BLOOD GLUCOSE WAS OVER 600 MG/DL, ASSOCIATED WITH AN ALLEGED INACCURATE DELIVERY ISSUE. 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 BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA WHILE ON THE INSULIN PUMP, AND THE PUMP COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR.

  Patient problems: Hyperglycemia

  MAUDE report 7211789 ↗
• InjuryJan 19, 2018Failure to Prime; Failure to Prime

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 400 MG/DL WITH LARGE KETONES ASSOCIATED WITH AN ALLEGED LOSS OF PRIME ISSUE. REPORTEDLY, THE PATIENT DISCONTINUED PUMP THERAPY AND WAS TREATED AT THE HOSPITAL BY THEIR HEALTH CARE PROVIDER WITH INTRAVENOUS FLUIDS. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS NOTED THAT THIS OCCURRED 2 OR MORE TIMES EVEN AFTER THE PATIENT USED A CARTRIDGE FROM ANOTHER BOX AND OCCURRED WITH AT LEAST 3 SEPARATE CARTRIDGES FROM 2 SEPARATE BOXES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH AN ALLEGED LOSS OF PRIME ISSUE.

  Patient problems: Hyperglycemia; No Code Available

  MAUDE report 7206894 ↗
• InjuryJan 17, 2018Failure to Prime; Failure to Prime

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 400 MG/DL WITH LARGE KETONES ASSOCIATED WITH AN ALLEGED LOSS OF PRIME ISSUE. REPORTEDLY, THE PATIENT DISCONTINUED PUMP THERAPY AND WAS TREATED AT THE HOSPITAL BY THEIR HEALTH CARE PROVIDER WITH INTRAVENOUS FLUIDS. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS NOTED THAT THIS OCCURRED 2 OR MORE TIMES EVEN AFTER THE PATIENT USED A CARTRIDGE FROM ANOTHER BOX AND OCCURRED WITH AT LEAST 3 SEPARATE CARTRIDGES FROM 2 SEPARATE BOXES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH AN ALLEGED LOSS OF PRIME ISSUE.

  Patient problems: Hyperglycemia; No Code Available

  MAUDE report 7201492 ↗
• InjuryDec 30, 2017Inaccurate Delivery; Inaccurate Delivery

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT EXPERIENCED AN UNSPECIFIED BLOOD GLUCOSE (BG) LEVEL, INITIATED A 911/EMERGENCY PROTOCOL AND WAS TREATED IN THE EMERGENCY ROOM (ER) BY A HEALTHCARE PROVIDER ON THE SAME DATE WITH NO REPORTED ADDITIONAL SYMPTOMS ASSOCIATED WITH AN ALLEGED INACCURATE DELIVERY. THE PATIENT REPORTED THAT THEY WERE SEEN IN THE ER DUE TO THE PUMP ALLEGEDLY NOT WORKING. INFORMATION ABOUT THE TYPE OF TREATMENT RECEIVED COULD NOT BE OBTAINED. IT COULD NOT BE DETERMINED WHETHER OR NOT THE PATIENT CONTINUED PUMP THERAPY. TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS) COULD NOT BE COMPLETED THEREFORE THE UNSPECIFIED PUMP ISSUE COULD NOT BE CONFIRMED. FOLLOW-UP CALLS FROM CTS S WERE MADE TO ATTEMPT TO CONTACT THE PATIENT BUT CONTACT WAS UNSUCCESSFUL AND NO ADDITIONAL INFORMATION WAS OBTAINED. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SENT. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT REQUIRING AN INITIATION OF A MEDICAL INTERVENTION AND THE PUMP COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR.

  Patient problems: No Code Available

  MAUDE report 7156298 ↗
• InjuryDec 24, 2017Use of Device Problem; Use of Device Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OF 344 MG/DL WITH ABDOMINAL PAIN, EXTREME DROWSINESS, NAUSEA, FEELING A ¿FLU-LIKE¿ SICKNESS, EXTREME FATIGUE AND A LOSS OF APPETITE ASSOCIATED WITH AN ALLEGED HISTORY SETTINGS ISSUE. IT WAS ALSO REPORTED THAT THE PATIENT WAS ¿PUSHING FLUIDS¿. REPORTEDLY, THE PATIENT REMAINED ON THE PUMP AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. IT WAS REPORTED THAT THE PATIENT RECEIVED AN EMPTY CARTRIDGE WARNING OVER-NIGHT AND DID NOT REALIZE IT UNTIL THE MORNING, WHICH CAUSED THE PATIENT TO HAVE A HIGH BG LEVEL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED HYPERGLYCEMIA WAS RELATED TO USE ERROR OF THE PRODUCT.

  Patient problems: Abdominal Pain; Hyperglycemia; Lethargy

  MAUDE report 7145277 ↗