OneTouch Ping 10543200Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 10840406101058), received between Oct 20, 2016 and May 14, 2020 — classified as 1 death, 45 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (26 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 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 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 PUMP HAD NO POWER AND THE BATTERY COMPARTMENT WAS CRACKED. THE THREADS OF THE BATTERY CAP WERE ALSO REPORTED STRIPPED. 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 10058936 ↗
• MalfunctionNov 5, 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 9278080 ↗
• MalfunctionOct 25, 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 9239231 ↗
• MalfunctionOct 25, 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 BATTERY COMPARTMENT WAS 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 9238626 ↗
• MalfunctionOct 22, 2019Failure to Sense; Failure to Sense

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THERE WAS NO INDICATION THAT THE DEVICE 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 9218542 ↗
• MalfunctionOct 18, 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. IT WAS REPORTED THAT THE OK/ENTER BUTTON WAS UNDER-RESPONSIVE. 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 INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9207868 ↗
• MalfunctionOct 18, 2019Electrical /Electronic Property Problem; Moisture Damage; Structural Problem; Electrical /Electronic Property Problem; Moisture Damage; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE WITH 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 9207808 ↗
• MalfunctionOct 18, 2019No Display/Image; Moisture Damage; Structural Problem; No Display/Image; Moisture Damage; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DAMAGED W/ MOISTURE) ISSUE. IT WAS REPORTED THERE WAS MOISTURE BEHIND THE DISPLAY. 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 9207492 ↗
• 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 052/053/054/055 SLEEP) 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 9203955 ↗
• MalfunctionOct 17, 2019No Display/Image; Moisture Damage; No Display/Image; Moisture Damage

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (CLOUDY W/ MOISTURE) 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 9201473 ↗
• MalfunctionOct 7, 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 9160840 ↗
• MalfunctionOct 2, 2019Structural Problem; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION ALSO REVEALED MULTIPLE CRACKS IN THE BATTERY COMPARTMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 21-AUG-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144556 ↗
• MalfunctionSep 26, 2019Structural Problem; Structural Problem

  ON 20-NOV-2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. 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 9125907 ↗
• MalfunctionSep 25, 2019No Display/Image; Moisture Damage; No Display/Image; Moisture Damage

  ON 02-AUG-2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (CLOUDY W/ MOISTURE) 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 9115105 ↗
• MalfunctionJun 28, 2019Failure to Read Input Signal; Failure to Read Input Signal

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THE PATIENT EXPERIENCED HYPERGLYCEMIA WITH BLOOD GLUCOSE >500 MG/DL WITH ADDITIONAL SYMPTOMS OF POLYURIA, POLYDIPSIA AND NAUSEA. THE PATIENT REPORTEDLY DID NOT RECEIVE ANY TREATMENT OVER OR ABOVE THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. THE REPORTER ALLEGED ALL THE KEYPAD BUTTONS ON THE PUMP WERE UNRESPONSIVE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED SERIOUS INJURY ASSOCIATED WITH A BUTTON/KEYPAD UNRESPONSIVENESS ISSUE.

  Patient problems: Hyperglycemia; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 8745177 ↗
• MalfunctionApr 25, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. IT WAS ALLEGED THAT THE PUMP WENT BACK TO THE VERIFICATION SCREEN WITHOUT THE USER PRESSING ANYTHING. 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 8550903 ↗
• MalfunctionApr 25, 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) 2018, 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 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 8550783 ↗
• MalfunctionApr 25, 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. IT WAS REPORTED THAT THERE WAS DAMAGE TO THE BATTERY COMPARTMENT AND THE BATTERY CAP WAS UNABLE TO TIGHTEN SECURELY. 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 8550300 ↗
• MalfunctionApr 18, 2019Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THE PUMP EMITTED ERROR CODES. THE REPORTER DID NOT CLARIFY THE ISSUE FURTHER. ANIMAS CUSTOMER SUPPORT MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION; HOWEVER, THE REPORTER DID NOT RESPOND. 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. 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 ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527152 ↗
• DeathMar 20, 2019Use of Device Problem; Use of Device Problem

  ON (B)(6) 2019, THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 44 MG/DL WITH CONFUSION AND COGNITIVE IMPAIRMENT ASSOCIATED WITH AN ALLEGED INACCURATE DELIVERY. REPORTEDLY, THE PATIENT WAS FOUND UNCONSCIOUS WITH A BLOOD GLUCOSE OF 44 MG/DL. THE PATIENT DISCONTINUED PUMP THERAPY AND WAS TREATED WITH INTRAVENOUS GLUCOSE AND OTHER TREATMENT. THE PATIENT WAS TAKEN TO THE HOSPITAL VIA EMERGENCY MEDICAL SERVICES BUT WAS PRONOUNCED DEAD AT THE TIME OF ARRIVAL. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS ALSO REPORTED THAT ON THE DAY OF THE PATIENT¿S DEATH, THE PATIENT WAS TAKING OXYCODONE FOR PAIN. THE PATIENT GAVE THEMSELVES A BOLUS OF 7.7 UNITS AND THE PATIENT THOUGHT THE PUMP SAID 0.0 UNITS OF THE 7.7 UNITS WERE DELIVERED. IT WAS FOUND THAT 6.7 OF THE 7.7 UNITS WERE DELIVERED. THE PATIENT THEN CHANGED THE IFS AND THE CARTRIDGE AND ANOTHER BOLUS OF 7.7 UNITS WAS GIVEN. IT WAS ALSO REPORTED THAT THERE WAS A CHANGE IN PHYSICAL ACTIVITY LEVEL WITHOUT ADJUSTMENT TO INSULIN REGIMEN, CHANGE IN MEDICATION, CHANGE IN STRESS LEVEL, CHANGE IN PAIN LEVEL, A RECENT SEVERE HYPOGLYCEMIA, AND OVERRIDING DOSAGE RECOMMENDED BY BOLUS CALCULATOR FEATURE. THIS COMPLAINT

  Patient problems: Confusion/ Disorientation; Death; Hypoglycemia

  MAUDE report 8437249 ↗
• MalfunctionJan 3, 2019Pumping Problem; Pumping Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A OTHER (UNUSUAL ISSUE) ISSUE. THE REPORTER ALLEGED THAT THE CARTRIDGE WAS NOT ABLE TO BE FULLY LOADED INTO THE PUMP AND THE CARTRIDGE PROTRUDES FROM THE CARTRIDGE COMPLAINT. NO FURTHER INFORMATION WAS PROVIDED. 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 CARTRIDGE LOADING ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8213998 ↗
• MalfunctionDec 7, 2018Failure to Prime; Failure to Prime

  THE REPORTER CONTACTED ANIMAS ON (B)(6) 2018 ALLEGING THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY EVIDENCED BY BLOOD GLUCOSE MEASURING BETWEEN 400-500 MG/DL DURING THE NIGHT WITH HIGH URINARY KETONES. THE REPORTER ALSO STATED THAT THE PATIENT¿S BLOOD GLUCOSE MEASUREMENT ON THE METER HAS MEASURED AS ¿HIGH¿ ON THE DISPLAY INDICATING BLOOD GLUCOSE LEVEL =600 MG/DL. THE REPORTER DID NOT PROVIDE ANY INFORMATION REGARDING TREATMENT THE PATIENT MAY HAVE RECEIVED ASSOCIATED WITH THE REPORTED HYPERGLYCEMIC EVENT(S). THE REPORTER ALLEGED THE PUMP WAS EXPERIENCING AN ISSUE WITH LOSING PRIME BEGINNING (B)(6) 2018 ¿CAUSING THE PATIENT¿S BLOOD GLUCOSE TO GO SUPER HIGH¿. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY ASSOCIATED WITH A LOSS OF PRIME ISSUE.

  Patient problems: Hyperglycemia

  MAUDE report 8141302 ↗
• InjuryNov 14, 2018Use of Device Problem; Use of Device Problem

  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 LEVEL OF 40 MG/DL WITH SYMPTOMS OF BEING ¿GLASSY-EYED¿ AND LOSS OF CONSCIOUSNESS. THE PATIENT WAS TREATED WITH FOOD AND SUGAR CUBES BEFORE PARAMEDICS WERE CALLED AND THE PATIENT WAS TAKEN TO A HOSPITAL. THE PATIENT WAS UNSURE OF WHAT EVENTS LEAD UP TO THE LOW BLOOD GLUCOSE EXCURSION, BUT A REVIEW OF THE PUMP HISTORY INDICATED A LARGER THAN EXPECTED PRIME VOLUME OF INSULIN. THIS INDICATES THAT THE PATIENT MAY HAVE INADVERTENTLY INFUSED INSULIN IF THEY HAD PRIMED THE PUMP WHILE STILL ATTACHED. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT WHILE ON THE PUMP AS A RESULT OF USE ERROR OF THE DEVICE.

  Patient problems: Dysphasia; Hypoglycemia; Loss of consciousness

  MAUDE report 8068857 ↗
• MalfunctionSep 24, 2018Pumping Problem; Pumping Problem

  ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT THERE WAS AN ISSUE WITH THE BASAL HISTORY WITH THEIR PUMP. THE REPORTER STATED THAT THERE WERE SEGMENTS WHERE THERE WERE 0 UNITS DELIVERED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE INDICATES THAT THERE WAS A DELIVERY PROBLEM. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7901504 ↗
• InjurySep 6, 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 487 MG/DL WITH SYMPTOMS OF EXCESS THIRST AND URINATION. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE NORMAL COURSE OF DIABETES MANAGEMENT. THE REPORTER REVIEWED THE PUMP WITH A CUSTOMER TECHNICAL SUPPORT REPRESENTATIVE AND FOUND NO MECHANICAL FAILURE OF THE PUMP. THE REPORTER STATED THAT THE DELIVERED BOLUSES WERE BEING MANUALLY CALCULATED. 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; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 7850171 ↗