OneTouch Ping 10543000Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10840406100990), received between Nov 18, 2016 and Feb 27, 2020 — classified as 35 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Device Issue” (15 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 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2020Defective Alarm; Defective Alarm

  ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS, ALLEGING AN AUDIO TONE/VIBRATION ( INTERMITTENT VIBRATION) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED 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 9762647 ↗
• MalfunctionFeb 25, 2020No Display/Image; No Display/Image

  ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS ALLEGING A DISPLAY (MISALIGNED) 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 9752232 ↗
• MalfunctionDec 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 9466085 ↗
• MalfunctionOct 25, 2019Device 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 064) ISSUE. IT WAS REPORTED THAT CALL SERVICE ALARM 064 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 9239399 ↗
• MalfunctionOct 22, 2019Moisture Damage; Failure to Read Input Signal; Moisture Damage; Failure to Read Input Signal

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE.THERE IS NO INDICATION THAT THE PRODUCT ISSUE 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 9220847 ↗
• MalfunctionOct 22, 2019Premature Discharge of Battery; Structural Problem; Premature Discharge of Battery; Structural Problem

  ON (B)(6) 2019, 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 9219657 ↗
• MalfunctionOct 22, 2019Failure to Read Input Signal; Failure to Read Input Signal

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THERE IS NO INDICATION THAT THE PRODUCT ISSUE 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 9218492 ↗
• MalfunctionOct 22, 2019Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 078) ISSUE. IT WAS 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 9218324 ↗
• MalfunctionOct 18, 2019Structural Problem; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS REPORTED THAT THE CARTRIDGE COMPARTMENT WAS 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 CARTRIDGE COMPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9207365 ↗
• MalfunctionOct 17, 2019Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 064) ISSUE. IT WAS REPORTED THAT CALL SERVICE ALARM 064 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 9204222 ↗
• MalfunctionOct 17, 2019Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 078) ISSUE. IT WAS 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 9204022 ↗
• MalfunctionOct 17, 2019Moisture Damage; Moisture Damage

  THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED INTERNAL MOISTURE DAMAGE TO THE PRINTED CIRCUIT BOARD CAUSING THE PUMP TO BE UNRESPONSIVE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 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 9203888 ↗
• MalfunctionOct 16, 2019No Display/Image; Moisture Damage; No Display/Image; Moisture Damage

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. IT WAS REPORTED THERE WAS MOISTURE IN THE BATTERY COMPARTMENT AND THE DISPLAY WAS BLANK. 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 9197566 ↗
• MalfunctionSep 27, 2019Electrical /Electronic Property Problem; Moisture Damage; Electrical /Electronic Property Problem; Moisture Damage

  ON 06-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 9128784 ↗
• MalfunctionSep 27, 2019Moisture Damage; Moisture Damage

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE. IT WAS REPORTED THAT THERE WAS RUST IN THE BATTERY COMPARTMENT AFTER THE PATIENT WAS SWIMMING WITH THE PUMP. IT WAS REPORTED THAT 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 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 9128695 ↗
• MalfunctionSep 27, 2019Image Display Error/Artifact; Image Display Error/Artifact

  ON 28-AUG-2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. IT WAS REPORTED THE DISPLAY SCREEN TURNED RED AND YELLOW WHEN THE CONTRAST DEFAULT WAS RESET. 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 9127763 ↗
• MalfunctionSep 20, 2019Failure to Read Input Signal; Structural Problem; Failure to Read Input Signal; Structural Problem

  ON 17-SEPT-2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (AUDIO BOLUS BUTTON DAMAGE PRIOR TO TACTILE CHANGE) ISSUE. IT WAS REPORTED THAT THE AUDIO BOLUS BUTTON WAS DAMAGED AND OVER-RESPONSIVE. IT WAS REPORTED THAT THE AUDIO BOLUS BUTTON FELL OFF. REPORTER ALLEGES THE AUDIO BOLUS BUTTON WAS THEN PUT BACK ON AND BECAME OVER-RESPONSIVE. REPORTER ALLEGES AUDIO BOLUS BUTTON WAS THEN REMOVED FROM THE PUMP SO THAT A BOLUS COULD BE COMPLETED AS THE OVER-RESPONSIVENESS OF THE AUDIO BOLUS BUTTON WAS CANCELLING THE BOLUS. REPORTER WAS UNABLE TO COMPLETE TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT AT THE TIME OF THE CALL. CUSTOMER SUPPORT MADE AN ATTEMPT TO CONTACT THE REPORTER IN FOLLOW UP, AT WHICH TIME REPORTER REFUSED TO COMPLETE TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE HAS THE ABILITY TO RESULT IN INADVERTENT OR INCORRECT BOLUSES WHICH MAY RESULT IN OVER OR UNDER DELIVERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9099462 ↗
• MalfunctionJul 11, 2019Premature Discharge of Battery; Premature Discharge of Battery

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THERE WAS A POWER ISSUE. IT WAS ALLEGED THAT THERE WAS A BATTERY LIFE 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 8781221 ↗
• MalfunctionApr 25, 2019Moisture Damage; Structural Problem; Moisture Damage; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DAMAGED W/ MOISTURE) ISSUE. THE REPORTER ALLEGED THERE WERE SUPERFICIAL SCRATCHES ON THE DISPLAY LENS, BUT THE DISPLAY COULD BE READ SAFELY. THE REPORTER FURTHER ALLEGED MOISTURE IN THE DISPLAY SCREEN. 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 8550425 ↗
• MalfunctionApr 25, 2019Structural Problem; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE) ISSUE. THE REPORTER ALLEGED THAT THE BATTERY COMPARTMENT WAS FOUND TO BE DAMAGED WITH STRIPPED THREADS. IT WAS ALSO ALLEGED THAT THE BATTERY CAP WOULD NOT SECURE TO 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 OR THE CARTRIDGE COMPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8550156 ↗
• MalfunctionMar 4, 2019Pumping Problem; Pumping Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS REGARDING A POSSIBLE INACCURATE DELIVERY ISSUE WITH THE PUMP. THE REPORTER DID NOT PROVIDE ANY INFORMATION REGARDING WHAT THE POSSIBLE PUMP ISSUE WAS. THE REPORTER STATED THEY COULD NOT STAY ON THE PHONE WITH ANIMAS CUSTOMER SUPPORT BECAUSE THEY HAD TO TEND TO THE PATIENT WHO WAS EXPERIENCING LOW BLOOD GLUCOSE. A BLOOD GLUCOSE MEASUREMENT WAS NOT PROVIDED TO ANIMAS CUSTOMER SUPPORT; THE REPORTER DID NOT ALLEGE THE PATIENT EXPERIENCED A SERIOUS INJURY ASSOCIATED WITH THE USE OF THE PUMP. ANIMAS CUSTOMER SUPPORT REQUESTED THE REPORTER CALL BACK TO COMPLETE TROUBLESHOOTING OF THE PUMP. ANIMAS CUSTOMER SUPPORT MADE SEVERAL SUBSEQUENT ATTEMPTS TO COMPLETE TROUBLESHOOTING OF THE DEVICE. HOWEVER, DURING ONE SUCCESSFUL CONTACT WITH THE PATIENT, THE PATIENT STATED THEY COULD NOT COMPLETE TROUBLESHOOTING AT THE TIME. ANIMAS CUSTOMER SUPPORT MADE AN ADDITIONAL ATTEMPT TO CONTACT THE PATIENT TO COMPLETE TROUBLESHOOTING, BUT THE PATIENT HAS NOT RESPONDED. 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 HIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8386390 ↗
• InjuryDec 7, 2018Inaccurate Delivery; Inaccurate Delivery

  THE REPORTER CONTACTED ANIMAS ON (B)(6) 2018 ALLEGING THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY EVIDENCED BY BLOOD GLUCOSE MEASURING 622 MG/DL WITH LARGE URINARY KETONES AND ABDOMINAL PAIN. THE PATIENT REPORTEDLY DID NOT RECEIVE ANY TREATMENT ABOVE OR BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. THE REPORTER ALLEGED THAT BEGINNING ON (B)(6) 2018, THE PUMP MAY NOT HAVE BEEN DELIVERING AS IT SHOULD AND THERE WERE CANCELLED BOLUSES WHEN NO ONE HAD TOUCHED THE PUMP. ANIMAS CUSTOMER SUPPORT WAS UNABLE TO COMPLETE TROUBLESHOOTING ON THE PUMP AT THE TIME OF THE REPORTER¿S CALL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY ASSOCIATED WITH AN ALLEGED INACCURATE DELIVERY ISSUE.

  Patient problems: Abdominal Pain; Hyperglycemia

  MAUDE report 8141779 ↗
• InjuryNov 9, 2018Inaccurate Delivery; Inaccurate Delivery

  THE REPORTER CONTACTED ANIMAS ON (B)(6) 2018 ALLEGING THE PATIENT EXPERIENCED HYPERGLYCEMIA WITH NAUSEA WHILE ON INSULIN PUMP THERAPY EVIDENCED BY BLOOD GLUCOSE MEASURING 310 MG/DL. THE PATIENT REPORTEDLY TREATED THEMSELVES WITH INSULIN VIA INJECTION. THE REPORTER ALLEGED THE PUMP WAD DELIVERING INACCURATELY AND HAS BEEN GETTING WORSE SINCE (B)(6) 2018. THE REPORTER DECLINED TO TROUBLESHOOT THE PUMP WITH ANIMAS CUSTOMER SUPPORT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY ASSOCIATED WITH AN INACCURATE DELIVERY OF INSULIN ISSUE.

  Patient problems: Hyperglycemia; Nausea

  MAUDE report 8056209 ↗
• InjuryOct 25, 2018Use of Device Problem; Device Displays Incorrect Message; Fail-Safe Problem; Use of Device Problem; Device Displays Incorrect Message; Fail-Safe Problem

  THE REPORTER CONTACTED ANIMAS ON (B)(6) 2018 ALLEGING THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY EVIDENCED BY BLOOD GLUCOSE (BG) MEASURING 547MG/DL WITH DROWSINESS. THE PATIENT ALLEGED THAT ELEVATION OCCURRED FROM RECEIVING CALL SERVICE ALARM (064) DUE TO BLOCKAGE IN TUBING. THE PATIENT REPORTS BEING OUT OF CARTRIDGES AND WAS RE-USING THEM. CUSTOMER TECHNICAL SUPPORT (CTS) WAS UNABLE TO COMPLETE TROUBLESHOOTING OF THE CALL SERVICE ALARM AT THE TIME OF THE INITIAL CALL. A FOLLOW UP CALL BY CTS TO COMPLETE TROUBLESHOOTING WAS DONE. AT THAT TIME THE REPORTER ALLEGED PATIENT WAS HOSPITALIZED FOR THE HIGH BG ISSUE. THE REPORTER WAS UNABLE TO PROVIDE ANY DETAILS OF THE HOSPITALIZATION. NO FURTHER TROUBLESHOOTING OF THE PUMP WAS ABLE TO BE COMPLETED. AN ADDITIONAL ATTEMPT WAS MADE TO COMPLETE TROUBLESHOOTING BUT WAS UNSUCCESSFUL. THIS COMPLAINT IS BEING REPORTED FOR ALLEGED HYPERGLYCEMIA ASSOCIATED WITH PUMP USE FOR WHICH IT WAS DETERMINED THAT DIABETES MANAGEMENT RELATED TO THE LACK OF PROPER SUPPLIES AS WELL AS TRAINING MISUSE ASSOCIATED WITH THE RE-USE OF SINGLE-USE SUPPLIES WHICH MAY HAVE BEEN ASSOCIATED WITH THE OCCLUSION DURING THE PRIME STEP AS INDICATED BY

  Patient problems: Hyperglycemia; Lethargy

  MAUDE report 8004275 ↗
• InjurySep 17, 2018Use of Device Problem; Use of Device Problem

  ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 500 MG/DL WITH SYMPTOMS OF LARGE KETONES, THIRST, URINATION, AND VOMITING. THE PATIENT WAS RECEIVING INTRAVENOUS FLUIDS AND INSULIN VIA INJECTIONS WHILE AT THE HOSPITAL. THE REPORTER STATED THAT THERE WAS AN ISSUE WITH THE PUMP¿S TIME AND DATE SETTINGS CAUSING THE PATIENT TO RECEIVE PROGRAMMED NIGHT TIME BASAL RATES DURING THE DAY AND DAYTIME BASAL RATES AT NIGHT. DURING TROUBLESHOOTING IT WAS DETERMINED THAT THE PUMP WAS POWERING ON TO THE VERIFY SCREEN FOR THE DATE AND TIME. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT AS A RESULT OF THE IMPROPER TIME BEING SELECTED IN THE PUMP.

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

  MAUDE report 7880583 ↗