Mio® MMT-943Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 05705244007499), received between Feb 12, 2018 and Aug 17, 2026 — classified as 1 death, 31 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (58 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 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268952 ↗
• MalfunctionNov 7, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKING AT QUICK RELEASE EVENT ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR 1 DAY. BLOOD GLUCOSE LEVELS REPORTED DURING THE EVENT WAS 600 MG/DL. THE PATIENT WAS HOSPITALIZED FOR LESS THAN 24 HOURS DUE TO HIGH BLOOD GLUCOSE. PATIENT WAS TREATED WITH INTRAVENOUS INSULIN DRIP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 20631548 ↗
• MalfunctionSep 6, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ITALY. IT WAS REPORTED THAT THE PATIENT FACED OCCLUSION IN THE TUBING EVENT ON 03-AUG-2024. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154135 ↗
• MalfunctionJul 20, 2024Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO BENT CANNULA WHICH RESULTED IN HIGH BG 400 MG/DL. A CORRECTION BOLUS WAS ADMINISTERED WITH QUICK BG RECOVERY NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 19786593 ↗
• InjuryJul 7, 2024No Apparent Adverse Event; No Apparent Adverse Event

  UNOMEDICAL REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED BY MOTHER THAT A 7 YEAR OLD MALE SUBJECT HAD A DEVICE [POSSIBLE] RELATED ADVERSE EVENT WITH A DIAGNOSIS OF SEVERE HYPERGLYCEMIA. THE SUBJECT RECOVERED WITHOUT SEQUELA ON (B)(6) 2019. HIGH GLUCOSE VALUE OF 354 MG/DL AND KETONES OF 3.5 REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 19686715 ↗
• InjuryJul 7, 2024No Apparent Adverse Event; No Apparent Adverse Event

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT A 7 YEAR OLD MALE SUBJECT HAD A DEVICE [POSSIBLE] RELATED ADVERSE EVENT WITH A DIAGNOSIS OF SEVERE HYPERGLYCEMIA. THE SUBJECT RECOVERED WITHOUT SEQUELA ON (B)(6) 2019. HIGH GLUCOSE VALUE OF 409 MG/DL AND KETONES OF 1.9 REPORTED. RESOLVED WITH BG OF 286 AND KETONES OF 0.08. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 19686713 ↗
• MalfunctionMay 23, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN EGYPT. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT FACED AN INFUSION SET TAPE WAS NOT STICKING EVENT. THE INFUSION SET WAS IN USE FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19379851 ↗
• MalfunctionMar 27, 2024Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES ON (B)(6) 2024, IT WAS REPORTED THAT 10-YEARS-OLD FEMALE CHILD PATIENT HAD INSULIN FLOW BLOCK AROUND 2:00 AM RESULTING IN NO INSULIN FOR THREE HOURS. HER BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT WAS 370 MG/DL AND KETONES WERE 1.8 MMOL/L WHICH RESOLVED TO 0.1 MMOL/L IN 1.5 HOURS AFTER CHANGING INFUSION SET. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 18989945 ↗
• MalfunctionNov 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING DETACHED AT THE NEEDLE AREA AND THE INFUSION SET DID NOT GO INTO THE BODY. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE PUMP WAS LOCATED AT THE ABDOMEN AS WELL. MOREOVER, THE INFUSION SET WAS JUST INSERTED HALFWAY. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10776630 ↗
• InjuryOct 13, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT ON (B)(6) 2020, A CHILD PATIENT FACED A DEVICE RELATED ADVERSE EVENT WITH A DIAGNOSIS OF URINARY TRACT INFECTION. THEREFORE, THE PATIENT WENT INTO URGENT CARE AND WAS PRESCRIBED ANTIBIOTIC FOR TEN DAYS. THE PATIENT HAD ELEVATED KETONE AND BLOOD GLUCOSE LEVELS DUE TO ILLNESS. MOREOVER, HE WAS PRESCRIBED WITH CEFDINIR 300 MG TWICE DAILY FOR 7 DAYS ON THE DAY OF INCIDENT ((B)(6) 2020). ON (B)(6) 2020, THE DOCTOR COUNSELED STATING THAT SYMPTOMS WERE IMPROVING BUT PATIENT CONTINUED COMPLAINING OF BACK PAIN. FURTHER, THE DOCTOR COUNSELED PATIENT TO DISCONTINUE CEFDINIR AND WROTE A NEW PRESCRIPTION FOR AUGMENTIN 500-125 MG TWICE DAILY FOR TEN DAYS. ACCORDING TO MEDICAL RECORDS, PATIENT HAD SYMPTOMS WHICH INCLUDED CHILLS, FEVER, ABDOMINAL PAIN, MILD NAUSEA, URINARY BOWEL CHANGES (MILD DYSURIA & FREQUENT URINATION), & BACK PAIN. ON (B)(6) 2020, ALL THE SYMPTOMS WERE RESOLVED AND RECOVERED WITHOUT SEQUELA. IN ANOTHER EVENT, ON (B)(6) 2020, THE CHILD PATIENT'S SITE WAS CHANGED AND THEN HE HAD A LOW CARBOHYDRATE DINNER. WHILE HE WAS RUNNING AROUND, THEY DID NOT NOTICE HIS BLOOD GLUCOSE LEVEL WAS RISIN

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 10668811 ↗
• MalfunctionOct 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 16-MAR-2021: FOLLOW UP INFORMATION WAS SUBMITTED TO UPDATE HEALTH EFFECT - IMPACT CODE AND COMPONENT CODE. MOREOVER, THE RESULT OF THE COMPLAINT INVESTIGATION (VISUAL INSPECTION) OF THE RETURNED USED DEVICE (1 SET) SHOWED THAT THE TUBING WAS DETACHED FROM THE TUBING-TUBING CONNECTOR (MISSING GLUE). BASED ON THE RESULT: TYPE OF INVESTIGATION CODE, INVESTIGATION FINDINGS CODE AND INVESTIGATION CONCLUSIONS CODE WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2020, IT WAS REPORTED BY THE PATIENT THAT WHEN SHE OPENED THE PACKAGE OF HER INFUSION SET, IT WAS NOTICED THAT THE TUBING WAS DETACHED FROM SET AT THE TUBING CONNECTOR. FURTHER, IT WAS FOUND THAT THE OTHER TUBING WAS NOT ATTACHED TO SET WHEN SHE OPENED IT. MOREOVER, THE INFUSION SETS WERE NOT STORED OR USED IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. ALSO, THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 140 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10654991 ↗
• MalfunctionSep 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2020, THE PATIENT REPORTED THAT WHEN SHE WOKE UP THIS MORNING, THE INFUSION SET'S TUBING WAS HANGING ON THE SITE AT THE SITE CONNECTOR AND CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 278 MG/DL. YESTERDAY, SHE INSERTED IT AND HER SITE LOCATION WAS LEFT SIDE OF HER ABDOMEN. THE PUMP WAS LOCATED ON THE SIDE OF HER SLEEP GOWN. MOREOVER, THE INFUSION SET HAD BEEN USED FOR THE FIRST DAY. REPORTEDLY, THE INFUSIONS SETS WERE NOT STORED OR USED IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 10565329 ↗
• MalfunctionSep 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 09-OCT-2020: FOLLOW UP INFORMATION WAS SUBMITTED AS RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 SET) SHOWED THAT THE GLUE IN THE TUBING CONNECTOR WAS MISSING (ONE DROP OF GLUE WAS FOUND ON CONNECTOR). BASED ON THE RESULT: TYPE OF INVESTIGATION CODE, INVESTIGATION FINDINGS CODE AND INVESTIGATION CONCLUSIONS CODE WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2020, THE PATIENT'S MOTHER REPORTED THAT HER SON'S INFUSION SET'S TUBING WAS DISCONNECTED FROM THE QUICK RELEASE WHEN THEY GOT IT OUT OF THE BOX AND IT WAS NOT YET INSERTED. MOREOVER, ON (B)(6) 2020 AROUND 10:30 PM, HE EXPERIENCED LOW BLOOD GLUCOSE LEVEL OF 33 MG/DL, HAD WEAKNESS AND HIS HANDS WERE COLD. FURTHER, THIS WAS PROLONGED TO (B)(6) 2020, AND THEY TRIED TO TREAT IT WITH FOOD AND GLUCOSE TABLETS. REPORTEDLY, THE INFUSIONS WERE STORED AT ROOM TEMPERATURE. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hypoglycemia

  MAUDE report 10492902 ↗
• MalfunctionSep 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING GOT DETACHED AT THE QUICK RELEASE. THE PATIENT OBSERVED INSULIN CAME OUT OF THE TUBING ABOUT ONE-TWO DAYS, AFTER THE SET WAS CHANGED. THIS ISSUE OCCURRED WITH FIVE SETS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10492829 ↗
• InjuryAug 19, 2020No Apparent Adverse Event; No Apparent Adverse Event

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN ISSUE WITH THE INFUSION SET, AS IT FELL OFF FROM HIS BODY, WHILE HE WAS SLEEPING AT NIGHT DUE TO HIM SWEATING. THIS ISSUE WAS AN ISOLATED/ONE-TIME INCIDENT (THE CUSTOMER USES TEGADERM TAPE OVER HIS INFUSION SETS). THEREFORE, IN THE MORNING OF (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE LEVEL OF 831 MG/DL DUE TO DIABETIC KETOACIDOSIS, WHERE HE RECEIVED AN INSULIN DRIP VIA INTRAVENOUS ROUTE. THE PATIENT WAS HOSPITALIZED FOR FIVE DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 10424469 ↗
• MalfunctionJul 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING FELL OUT AT THE SITE LOCATION. THE SITE LOCATION WAS HIS ABDOMEN. REPORTEDLY, THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 120 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10269846 ↗
• MalfunctionJul 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2020, A CHILD PATIENT'S MOTHER REPORTED THAT SIX OF THE INFUSION SET'S TUBING HAD DETACHED FROM THE SITE CONNECTOR, AND IT HAPPENED ABOUT A WEEK AND A HALF AGO. THE SITE LOCATION WAS AT THE PATIENT'S ABDOMEN AND THE INFUSION HAD BEEN USED FOR TWO DAYS. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. REPORTEDLY, THEY HAD NO IDEA HOW IT HAD HAPPENED, BUT CUT WAS PRETTY SURE IT WAS NOT BECAUSE OF A BENT / OR KINKED TUBING. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 300 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 10243407 ↗
• InjuryJun 26, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S MOTHER REPORTED THAT HER DAUGHTER EXPERIENCED NAUSEA, VOMITING, ABDOMINAL PAIN, DIFFICULTY IN BREATHING AND HIGH BLOOD GLUCOSE LEVEL. THEY TRIED TO TREAT IT WITH 20 UNITS OF INSULIN THROUGH THE PUMP AND WENT TO BED, BUT THE BLOOD GLUCOSE LEVEL WENT UP TO 300 MG/DL, AND THEN TO 429 MG/DL, THEN 678 MG/DL. FURTHER, THE INFUSION WAS LAST CHANGED ON (B)(6) 2020. SUBSEQUENTLY, ON (B)(6) 2020 AT 06:00 AM, THE PATIENT VISITED THE EMERGENCY ROOM AND CONSEQUENTLY, SHE WAS ADMITTED TO THE HOSPITAL IN THE INTENSIVE CARE UNIT, WITH BLOOD GLUCOSE LEVEL HIGHER THAN 600 MG/DL AND DIABETIC KETOACIDOSIS. DURING HOSPITALIZATION, THE PATIENT RECEIVED AN INSULIN DRIP AS CORRECTIVE TREATMENT AND TOOK HER INSULIN PUMP OFF. NEXT MORNING ((B)(6) 2020), PATIENT'S BLOOD GLUCOSE LEVEL WAS AT 138 MG/DL AND SHE WAS STILL IN THE INTENSIVE CARE UNIT. THEY PUT HER INSULIN PUMP BACK ON HER AND THE NEXT THING SHE WAS BACK UP TO 300 MG/DL. AFTER, STAYING FOR 17 HOURS IN THE HOSPITAL, WHEN THE PATIENT CAME HOME, SHE CHANGED HER SITE, AND FOUND THAT THERE WAS A KINK IN THE CANNULA. THEREFORE, SHE TOOK HER OLD SITE OUT AND PUT A NEW O

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 10199923 ↗
• MalfunctionJun 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2020, IT WAS REPORTED THAT THE PATIENT WOKE UP WITH TUBE BROKEN OFF AT THE TUBING CONNECTOR WHILE SLEEPING. THE SITE LOCATION WAS ON THE BACK OF HER HIP AND THE PUMP WAS ON THE SAME SIDE. THE INFUSION HAD BEEN USED FOR TWO DAYS. THE INFUSIONS WERE STORED, OR USED, IN A PLACE INSIDE, WHERE THEY WERE NOT EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. REPORTEDLY, THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THEIR BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10156632 ↗
• InjuryJun 3, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4).EVENT OCCURRED IN (B)(6).IT WAS REPORTED THAT A CHILD PATIENT FACED A BENT CANNULA AND EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 18.9 MMOL/L WITH KETONE LEVEL 3.3 MMOL/L. THIS ISSUE OCCURRED WITH THREE INFUSION SETS WHICH THEY INSERTED, AND THE PATIENT WENT HIGH. UPON REMOVAL OF THE SET, THE CANNULA WAS FOUND TO BE BENT. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY.NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 10113481 ↗
• MalfunctionJun 2, 2020Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S MOTHER REPORTED THAT THE INFUSION SET'S TUBING DETACHED WHEN THE SET WAS JUST ABOUT TO BE INSERTED. THE SITE LOCATION WAS THE PATIENT'S ABDOMEN. THE INFUSIONS WERE STORED AT THE HOME. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THEIR BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10108691 ↗
• MalfunctionJun 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4)0 EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS SLEEPING AND WOKE UP, THE INFUSION SET'S TUBING ALREADY DISCONNECTED AT THE QUICK RELEASE. THE SITE LOCATION WAS RIGHT SIDE OF PATIENT'S ABDOMEN AND THE PUMP WAS LOCATED ON THE RIGHT SIDE. MOREOVER, THE INFUSION HAD BEEN USED FOR THE FIRST DAY. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10108640 ↗
• MalfunctionMay 5, 2020Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ON 27-AUG-2020: FOLLOW UP INFORMATION WAS SUBMITTED TO UPDATE LOT NUMBER, EXPIRATION DATE AND RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICES (3 SETS) SHOWED THAT ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. BASED ON THE RESULT: DEVICE, METHOD, RESULT AND CONCLUSION CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2020, THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING DETACHED AT THE QUICK RELEASE WHILE THE PATIENT WAS IN PROCESS OF CHANGING. THEREFORE, THE INTRODUCER NEEDLE WAS HARD TO REMOVE. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE PUMP WAS LOCATED IN HER BRA. REPORTEDLY, THE INFUSIONS WERE STORED IN THE CABINET. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10023879 ↗
• MalfunctionApr 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE (B)(6). IT WAS REPORTED THAT WHILE THE PATIENT WAS SLEEPING, THE INFUSION SET'S TUBING HAD DETACHED CLOSE TO THE SITE LOCATION. FURTHER, THE PATIENT NOTICED IT WHEN SHE WOKE UP, AND IT WAS THE SECOND SET FROM THE BOX BUT THE FIRST ONE WORKED FINE. SHE HAD A SET CHANGE AND IT WAS GOING WELL. THE SITE LOCATION WAS HER LEFT LEG AND THE PUMP WAS LOCATED ON THE SAME SIDE, CLIPPED ON THE POCKET. MOREOVER, THE INFUSION HAD BEEN USED FOR TWO DAYS. REPORTEDLY, THE INFUSIONS WERE STORED IN A BOX IN THE BEDROOM (NO EXTREME TEMPERATURES). THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9961305 ↗
• MalfunctionMar 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT WHILE INSERTION, THE INFUSION SET'S TUBING CAME APART AS THE WHOLE STICKY PIECE FELL APART. THEREFORE, THE PATIENT COULD NOT USE IT. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE PUMP WAS LOCATED ON THE TABLE. MOREOVER, THE INFUSION WAS NOT EVEN USED FOR A DAY. REPORTEDLY, THE INFUSIONS WERE STORED IN THE BATHROOM IN ROOM TEMPERATURE. REPORTEDLY, THERE WAS NO STRESS OR PULL ON THE TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9864145 ↗