Animas Vibe 13920000 (UDI 10840406103229)Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10840406103229), received between Jun 29, 2017 and Mar 31, 2020 — classified as 1 death, 9 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (13 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 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2020Pumping Problem; Pumping Problem

  ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE ¿PUMP HE (PATIENT) LOST BUT THE PUMP MALFUNCTIONED AND CAUSED HIM TO BE HOSPITALIZED¿. CUSTOMER TECHNICAL SUPPORT (CTS) WAS UNABLE TO DETERMINE WHAT THE ISSUES WERE WITH THE PUMP. TROUBLESHOOTING COULD NOT BE COMPLETED AT THE TIME OF THE COMPLAINT. CTS 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 WAS HOSPITALIZED DUE TO ISSUES WITH THE PUMP. THE PUMP COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR.

  Patient problems: No Code Available

  MAUDE report 9903272 ↗
• MalfunctionJul 9, 2019Premature Discharge of Battery; Premature Discharge of Battery

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. 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 8770885 ↗
• InjuryJul 2, 2019Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem

  THE PATIENT CONTACTED ANIMAS ON (B)(6) 2019 ALLEGING THE PUMP POWERED OFF DURING THE NIGHT WITHOUT THE PATIENT¿S AWARENESS. THE REPORTER FURTHER STATED THAT THERE WAS A CRACK IN THE BATTERY COMPARTMENT OF THE PUMP. THE REPORTER DENIED DAMAGE TO THE BATTERY CAP AND DENIED MOISTURE IN THE PUMP. THE PATIENT REPORTEDLY EXPERIENCED HYPERGLYCEMIA WITH BLOOD GLUCOSE MEASURING 300 MG/DL WITH ASSOCIATED SYMPTOMS OF NAUSEA AND VOMITING. THE PATIENT REPORTEDLY DID NOT RECEIVE ANY TREATMENT ABOVE OR BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.

  Patient problems: Hyperglycemia; Nausea; Vomiting

  MAUDE report 8754591 ↗
• MalfunctionJul 2, 2019Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING AN ISSUE WITH LESS THAN EXPECTED BATTERY LIFE. THE REPORTER ALSO ALLEGED THE BATTERY COMPARTMENT WAS CRACKED. 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 8754367 ↗
• MalfunctionJul 1, 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. 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 8749655 ↗
• MalfunctionMar 5, 2019Premature Discharge of Battery; Premature Discharge of Battery

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING A POWER (BATTERY LIFE) ISSUE; SHORTER THAN EXPECTED BATTERY LIFE. 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 8391542 ↗
• MalfunctionMar 4, 2019No Audible Alarm; No Audible Alarm

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THE PUMP DID NOT EMIT AN AUDIO TONE WHEN THE PUMP GAVE A REPLACE BATTERY ALARM. THE REPORTER STATED THE VIBRATORY FEATURE OF THE PUMP WAS OPERATING PROPERLY. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE 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 8386879 ↗
• MalfunctionMar 4, 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 THE PUMP EXPERIENCED A COMMUNICATIONS ALARM THAT COULD NOT BE CLEARED FROM THE PUMP. 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 8386568 ↗
• MalfunctionFeb 7, 2019Structural Problem; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 18-DEC-2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8317737 ↗
• MalfunctionFeb 1, 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 A CALL SERVICE 064 ALARM. NO FURTHER INFORMATION WAS PROVIDED AND TROUBLESHOOTING WAS NOT ABLE TO BE COMPLETED AT THE TIME OF THE REPORT. ANIMAS CUSTOMER SUPPORT MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW-UP TO COMPLETE TROUBLESHOOTING OF THE DEVICE. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8296836 ↗
• MalfunctionOct 24, 2018Structural Problem; Structural Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8003347 ↗
• MalfunctionSep 24, 2018Pumping Problem; Pumping Problem

  ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS SLOWING DOWN. THE REPORTER WAS UNABLE TO COMPLETE TROUBLESHOOTING AT THE TIME OF THE CALL. THIS COMPLAINT IS BEING REPORTED BECAUSE IT IS POSSIBLE THAT THE ALLEGED ISSUE MIGHT CAUSE A PROBLEM WITH INSULIN DELIVERY. THERE WAS NO SERIOUS INJURY ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7901502 ↗
• MalfunctionSep 24, 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. THE REPORTER STATED THAT THE BATTERY CAP HAD A WORN TOP. 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 ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7901343 ↗
• DeathAug 16, 2018Failure to Read Input Signal; Failure to Read Input Signal

  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 600 MG/DL WITH SYMPTOMS OF NAUSEA, VOMITING, LETHARGY, CHEST PAIN, THIRST, AND SWEATING. THE PATIENT WAS BEING TAKEN TO THE HOSPITAL FOR THEIR BLOOD GLUCOSE EXCURSION. THERE WAS NO INFORMATION ON TREATMENT THAT THE PATIENT RECEIVED. THE REPORTER STATED THAT THE KEYPAD BUTTONS WERE UNRESPONSIVE. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE ON THE PUMP.

  Patient problems: Hyperglycemia; Nausea; Vomiting

  MAUDE report 7788407 ↗
• MalfunctionJul 30, 2018No Display/Image; Structural Problem; No Display/Image; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CRACKED DISPLAY (DAMAGED) 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 7730415 ↗
• MalfunctionJul 20, 2018Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THERE WAS A CALL SERVICE ALARM ISSUE. 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 THIS COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7706735 ↗
• MalfunctionJul 19, 2018Electrical /Electronic Property Problem; Moisture Damage; Structural Problem; Electrical /Electronic Property Problem; Moisture Damage; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE WITH MOISTURE INGRESS) ISSUE. IT WAS REPORTED THAT THE PUMP HAD INTERMITTENT POWER AND HAS A CRACK AND CORROSION IN THE BATTERY COMPARTMENT. THE PATIENT'S BLOOD GLUCOSE (BG) READING WAS UP TO 311 MG/DL WITHOUT SPECIFIC SYMPTOMS OF HYPERGLYCEMIA. IT WAS SAID THAT THE PATIENT GAVE A BOLUS TO HELP LOWER BG TO NORMAL. THIS INCIDENT DOES NOT MEET ANIMAS' DEFINITION OF 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 7703947 ↗
• MalfunctionJul 10, 2018Structural Problem; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. THE BATTERY COMPARTMENT WAS ALLEGED TO BE 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 7673492 ↗
• MalfunctionJul 10, 2018Moisture Damage; Temperature Problem; Moisture Damage; Temperature Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (TEMP - MOISTURE INGRESS W/ DMG) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673053 ↗
• InjuryJul 9, 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 500 MG/DL WITH TRACE KETONES, SYMPTOMS OF DEHYDRATION AND CONFUSION ASSOCIATED WITH AN ALLEGED HISTORY/SETTINGS ISSUE. REPORTEDLY, THE PATIENT DISCONTINUED PUMP THERAPY AND WAS TREATED AT THE HOSPITAL VIA INTRAVENOUS INSULIN VIA A HEALTH CARE PROVIDER. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS REPORTED THAT THE PATIENT ALLEGED THAT HE DID NOT THINK THE PUMP WAS DELIVERING AS IT SHOULD SPECIFICALLY WITH THE BOLUS SETTINGS. BOTH AND BASAL AND THE BOLUS RATES WERE DISPENSING WITHIN ACCEPTABLE RANGE. THE PATIENT DID ADMIT THAT HE LOWERED HIS BASAL RATE, WAS REUSING TUBING AND THERE WAS A DAILY INCREASE IN PHYSICAL ACTIVITY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH USER ERROR.

  Patient problems: Dehydration; Hyperglycemia; No Code Available

  MAUDE report 7669327 ↗
• MalfunctionJun 27, 2018Moisture Damage; Moisture Damage

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE. IT WAS REPORTED THAT MOISTURE WAS LOCATED IN THE BATTERY COMPARTMENT. 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 7642211 ↗
• MalfunctionJun 19, 2018Pumping Problem; Pumping Problem

  ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT THERE WAS AN INACCURATE DELIVERY ISSUE WITH THE PUMP. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 65 MG/DL AND SELF TREATED WITH GLUCAGON INJECTIONS. THE ALLEGED BLOOD GLUCOSE EXCURSION DOES NOT MEET ANIMAS CRITERIA FOR A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PUMP WAS NOT DELIVERING INSULIN ACCURATELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7613431 ↗
• InjuryJun 8, 2018Inaccurate Delivery; Inaccurate Delivery

  ON (B)(6) 2018, THE PATIENT REPORTED THAT SHE WAS IN THE HOSPITAL WITH A BLOOD GLUCOSE READING OF 656 MG/DL WITH LARGE KETONES. NO OTHER SIGNS OR SYMPTOMS OF HYPERGLYCEMIA WERE REPORTED. THE DATE OF THE ALLEGED HOSPITALIZATION WAS (B)(6) 2018. THE PATIENT COULD NOT SAY WHETHER OR NOT SHE RECEIVED TREATMENT AND REFUSED TO TROUBLESHOOT THE CAUSE OF THE HYPERGLYCEMIA. SHE CONTINUED INSULIN THERAPY ON THE SAME PUMP. MULTIPLE ATTEMPTS TO REACH THE PATIENT AGAIN WERE UNSUCCESSFUL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PUMP CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE HYPERGLYCEMIC EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 7583805 ↗
• InjuryJun 8, 2018Inaccurate Delivery; Inaccurate Delivery

  ON (B)(6) 2018, THE PATIENT CONTACTED ANIMAS REGARDING ANOTHER ISSUE (PUMP WAS ALLEGED TO SELF-SUSPEND). AT THE SAME TIME, THE PATIENT REVEALED THAT ON (B)(6) 2018 SHE WENT TO THE HOSPITAL'S EMERGENCY ROOM WITH A BLOOD GLUCOSE READING OF 30 MG/DL. THE PATIENT REPORTED SLURRED SPEECH AND A POSSIBLE LOSS OF CONSCIOUSNESS. SHE STATED THAT SHE WAS GIVEN IV GLUCOSE, FOOD/BEVERAGE, AND GLUCAGON. REPORTEDLY, THE PATIENT RESUMED INSULIN THERAPY ON THE SAME PUMP AT THAT TIME. THE PATIENT REFUSED TO TROUBLE SHOOT POSSIBLE CAUSES OF THE HYPOGLYCEMIA. MULTIPLE ATTEMPTS WERE MADE TO REACH THE PATIENT FOR FURTHER INVESTIGATION WITHOUT SUCCESS. THE COMPLAINT IS BEING REPORTED BECAUSE THE PUMP CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR IN THE HYPOGLYCEMIC EVENT.

  Patient problems: Dysphasia; Hypoglycemia

  MAUDE report 7583652 ↗
• MalfunctionMay 8, 2018Pumping Problem; Pumping Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER ALLEGED THE BASAL HISTORY DID NOT MATCH THE ACTIVE BASAL PROGRAM. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE LEVEL OF ABOVE 250 BUT BELOW 500, WITHOUT ANY OTHER SYMPTOMS OF HYPERGLYCEMIA. THIS INCIDENT DOES NOT MEET ANIMAS'S DEFINITION OF AN ADVERSE EVENT. THIS ISSUE IS BEING REPORTED BECAUSE 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 7495292 ↗