Mio® MMT-975Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 05705244007833), received between Jan 4, 2019 and Jun 12, 2026 — classified as 1 death, 26 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (69 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 99 reports, in the reporter's own words as published by the FDA.

• DeathJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS PASSED AWAY DUE TO AN UNKNOWN REASON ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481980 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA AND MANAGED IT BY TAKING SUGAR ON (B)(6) 2026.

  Patient problems: Hypoglycemia

  MAUDE report 24812711 ↗
• InjuryJul 26, 2024No Apparent Adverse Event; No Apparent Adverse Event

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 25-JUNE-2024, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS. THE PATIENT BLOOD GLUCOSE LEVELS AT TIME OF HOSPITALIZATION WERE 20 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hypoglycemia

  MAUDE report 19835570 ↗
• MalfunctionJul 20, 2024Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ITALY IT WAS REPORTED THAT THE PATIENT FACED AN INSULIN FLOW BLOCK ALARM AND INSULIN DID NOT EXIT TUBING DURING PRIMING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19786639 ↗
• InjuryJul 20, 2024Detachment 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 33 YEAR OLD MALE PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT. THE TUBING HAD DISCONNECTED FROM INFUSION SET WHICH CAUSED SEVERE HYPERGLYCEMIA. PATIENT EXPERIENCED NAUSEA AND KETONE LEVELS WERE 0.4 MMOL/L AT THE TIME OF EVENT. PATIENT TOOK MANUAL INJECTION TO ADDRESS THE EVENT AND REPLACED INFUSION SET AND RECOVERED PROMPTLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 19786340 ↗
• MalfunctionApr 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 THE PATIENT RECEIVED INSULIN FLOW BLOCKED ALARM AND THE BLOOD GLUCOSE LEVEL WENT OVER 300 MG/DL, WHICH THEY TRIED TO TREAT WITH AN INJECTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 19198786 ↗
• MalfunctionFeb 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GREECE ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING GOT DETACHED AT THE TUBING CONNECTOR. THE SITE LOCATION WAS RIGHT SIDE OF PATIENT'S ABDOMEN AND THE PUMP WAS LOCATED ON THE FRONT SIDE. MOREOVER, THE INFUSION SET HAD BEEN USED FOR TWO DAYS. 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 TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENTS BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16394882 ↗
• MalfunctionMar 16, 2022Detachment 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) 2021, IT WAS REPORTED THAT THE PATIENT KEPT GETTING INSULIN FLOW BLOCKED ALARM THAT MORNING AND HER PUMP WOKE HER UP, AS THE FLOW WAS BLOCKED. THE INFUSION SET HAD BEEN USED FOR A DAY AND A HALF. UPON INVESTIGATION OF THE RETURNED USED DEVICE (1 SET) IT WAS FOUND THAT THE GLUE IN THE TUBING CONNECTOR WAS MISSING (ONE DROP OF GLUE WAS FOUND ON THE CONNECTOR). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13783947 ↗
• MalfunctionJul 27, 2021Detachment 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) 2021, THE PATIENT REPORTED THAT INFUSION SET'S TUBING DISCONNECTED FROM THE QUICK RELEASE WHILE THE SET WAS CHANGED. FURTHER, THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. UPON VISUAL INSPECTION, OF THE RETURNED USED DEVICE (1 SET) IT WAS FOUND THAT THE GLUE IN THE TUBING CONNECTOR WAS MISSING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230902 ↗
• MalfunctionApr 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING QUALITY REVIEW PROCESS, UNOMEDICAL HAS CAPTURED THIS INCIDENT AND DEEMED IT REPORTABLE. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2019, IT WAS REPORTED THAT WHILE THE PATIENT WAS SLEEPING, THE INFUSION SET'S TUBING CAME APART FROM WHERE IT WAS CONNECTING. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE PUMP WAS LOCATED ON THE RIGHT SIDE. 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 11751332 ↗
• MalfunctionApr 21, 2021Detachment 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) 2021 , IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING BROKE OFF WHEN SHE WAS TRYING TO PUT ON. IT HAPPENED THREE DAYS AGO, AND THE PATIENT WAS UNSURE OF HER BLOOD GLUCOSE LEVELS. UPON INVESTIGATION OF THE RETURNED USED DEVICE (ONE SET), IT WAS FOUND THAT THE GLUE IN THE TUBING CONNECTOR WAS MISSING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699492 ↗
• MalfunctionMar 30, 2021Detachment 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 CAME APART AT THE SITE LOCATION. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE INFUSION SET HAD BEEN USED FOR ONE DAY. REPORTEDLY, THERE WAS STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO HER BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587937 ↗
• MalfunctionMar 23, 2021Detachment 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 HAD DETACHED CLOSE TO SITE LOCATION. THE SITE LOCATION WAS PATIENT'S UPPER THIGH AND THE PUMP WAS ON THE HIP AREA. THE INFUSION HAS BEEN USED FOR ONE DAY. REPORTEDLY, THE INFUSIONS WERE STORED IN A CARRY CASE. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548440 ↗
• MalfunctionJan 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 09-JAN-2021, THE PATIENT REPORTED THAT HIS INFUSION SET'S TUBING CAME APART AND WAS DROPPED ON THE FLOOR. MOREOVER, THERE WAS STRESS OR PULL ON THE TUBING, BUT THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. CURRENTLY, HIS BLOOD GLUCOSE LEVEL WAS 220 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11176328 ↗
• InjuryDec 9, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT, ON (B)(6) 2020, THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL, THEREFORE, THE PATIENT TRIED TO TREAT IT USING INSULIN PUMP. SUBSEQUENTLY, ON THE SAME DAY AT 01:00 PM, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO DIABETIC KETOACIDOSIS AND BLOOD GLUCOSE LEVEL OF 504 MG/DL. THE PATIENT STATED, THE INFUSION SET FELL OUT WHILE SLEEPING. DURING HOSPITALIZATION, THE PATIENT RECEIVED INTRAVENOUS INSULIN DRIP AS CORRECTIVE TREATMENT. THE PATIENT WAS HOSPITALIZED FOR FIVE DAYS. CURRENTLY, PATIENT'S BLOOD GLUCOSE LEVEL WAS 128 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 10973697 ↗
• InjuryNov 24, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED A BENT CANNULA ON (B)(6) 2020 (SATURDAY), AND IT WAS NOTICED WHEN THE INFUSION SET WAS REMOVED FROM THE BODY. SINCE THEN, THE PATIENT HAD NAUSEA AND THE BLOOD GLUCOSE LEVELS WERE HIGHER THAN THE NORMAL FOR TWO WEEKS, WHICH DID NOT COME DOWN. FURTHER, ON (B)(6) 2020, THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE WHICH THEY TRIED TO TREAT IT WITH A CORRECTION BOLUS, BUT IT DID NOT SHOW ANY CORRECTIONS. SUBSEQUENTLY, ON (B)(6) 2020, AT 01:00 PM, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM, WHERE THE PATIENT STAYED OVERNIGHT. CONSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO HYPERGLYCEMIA (594 MG/DL) AND DIABETIC KETOACIDOSIS, WHERE THE PATIENT RECEIVED INSULIN DRIP INTRAVENOUSLY AS CORRECTIVE TREATMENT. REPORTEDLY, FOR TWO DAYS, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS IN 300'S. MOREOVER, THE SITE LOCATION WAS RIGHT SIDE OF THE PATIENT'S ABDOMEN AND THE INFUSION SET WAS CHANGED TWO DAYS PRIOR TO THIS EVENT. THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR THREE DAYS. ON THE DAY OF THIS REPORT ((B)(6) 2020), IT WAS STATED THAT, LAST NIGHT, THE PATIENT CAME HOME AND WAS O

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 10894057 ↗
• MalfunctionSep 24, 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 THE PATIENT WAS SITING, AND REPLACING THE INFUSION SET, ITS TUBING DETACHED AT THE TUBING CONNECTOR. THE SITE LOCATION WAS THE PATIENT'S ABDOMEN AND THE INFUSION SET HAD BEEN USED FOR THE FIRST DAY. MOREOVER, THE INFUSION SETS WERE NOT STORED OR USED IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. FURTHER, THE 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 148 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10578396 ↗
• MalfunctionJun 4, 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 INFUSION SET'S TUBING CAME OFF AT THE QUICK RELEASE. THE SITE LOCATION WAS HER ABDOMEN. 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. UPON INVESTIGATION PERFORMED ON THE RETURNED USED DEVICE (1 USED SET), IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR (MISSING GLUE) AND ALSO A DROP OF GLUE ON THE TUBING CONNECTOR WAS FOUND. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10118154 ↗
• MalfunctionApr 3, 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 THE PATIENT WAS AT HOME, THE INFUSION SET'S TUBING CAME APART CLOSE TO THE SITE AT SITE CONNECTOR. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE PUMP WAS IN THE POCKET, ON THE SIDE OF INFUSION SET. MOREOVER, THE INFUSION WAS NOT EVEN INSERTED. THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN 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 PATIENT'S BODY NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9919515 ↗
• InjuryApr 2, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES THE PATIENT REPORTED THAT HE FACED A BENT CANNULA WHICH LED TO HIGH BLOOD GLUCOSE LEVELS. FURTHER, AT 10:00 AM, HE TRIED TO TREAT THIS ISSUE WITH A CORRECTION BOLUS, AS HIS BLOOD GLUCOSE WAS RISING AND BY AFTERNOON HIS BLOOD GLUCOSE LEVELS WERE EVEN HIGHER. MOREOVER BECAUSE OF THE STOMACH FLU WAS GOING AROUND AT WORK, AND WITH HIS FAMILY, HE FIGURED THAT HE WAS JUST COMING DOWN WITH SOMETHING, AND HIS BODY WAS JUST REACTING TO THE ILLNESS. FURTHERMORE, WHEN HE GOT HOME SLIGHTLY AFTER 1:00 PM, HE STARTED THROWING UP AND THREW UP AT LEAST TEN TIMES JUST AFTER MIDNIGHT. BY THURSDAY MORNING HIS WIFE FOUND HIM ON THE BATHROOM FLOOR MOSTLY UNRESPONSIVE AND ATTEMPTED TO GET HIM UP, BUT HE YELLED AT HER AND TOLD HER TO LEAVE HIM ALONE. SUBSEQUENTLY, HIS WIFE CALLED AT 911 TO BE RUSHED TO THE EMERGENCY ROOM, AS THE PATIENT EXPERIENCED DIABETIC KETOACIDOSIS AND HIS BLOOD GLUCOSE LEVEL WAS 950 MG/DL. ON (B)(6) 2020, ON THE DAY OF THE INCIDENT HIS BLOOD GLUCOSE LEVEL WAS REPORTED TO BE 850 MG/DL AND THEY TRANSPORTED HIM TO THE EMERGENCY ROOM, AND THEY FOUND HIS BLOOD GLUCOSE LEVEL WAS 950 MG/DL, SO THEY STARTED GIVING HIM

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9915183 ↗
• InjuryMar 24, 2020Device Handling Problem; Device Handling Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED SHE WAS TOO THIRSTY AND NOTICED THAT HER BLOOD GLUCOSE WAS CLIMBING HIGH. FURTHER, SHE NOTICED THAT THE INFUSION SET WAS NOT INSERTED TO HER PROPERLY, BUT SHE DID NOT FEEL THAT THE SITE WAS WET AND LEAKING AND SHE DID NOT REMEMBER GETTING ANY INSULIN FLOW BLOCKED ALARM. REPORTEDLY, SHE MENTIONED THAT SHE MAY HAVE RECEIVED AN ALARM BUT DID NOT COMPREHEND IT, BECAUSE SHE ALREADY HAD HIGH BLOOD GLUCOSE LEVEL. MOREOVER, SHE STATED THAT THE PUMP WAS DROPPED (FELL OFF), AND SHE NOTICED THAT INSULIN SUDDENLY CAME OUT OF THE PUMP. SUBSEQUENTLY, ON (B)(6) 2020 SHE WAS ADMITTED IN HOSPITAL FOR HIGH BLOOD GLUCOSE LEVEL OF 1575 MG/DL AND DIABETIC KETOACIDOSIS. DURING HOSPITALIZATION, SHE WAS ADMINISTERED INTRAVENOUS FLUIDS AND STEROIDS. ON (B)(6) 2020, SHE WAS RELEASED FROM THE HOSPITAL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9870890 ↗
• MalfunctionMar 4, 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 HAD DETACHED FROM THE CANNULA PART. THIS ISSUE OCCURRED WITH THREE INFUSION SETS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9784544 ↗
• InjuryMar 2, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT WAS ADMITTED IN THE INTENSIVE CARE UNIT WITH BLOOD GLUCOSE LEVEL OF 1200 MG/DL BECAUSE OF BENT CANNULA. DURING HOSPITALIZATION, THE PATIENT WAS TREATED WITH INSULIN DRIP AS CORRECTIVE TREATMENT. ON (B)(6) 2018, THE PATIENT WAS RELEASED FROM THE HOSPITAL. 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: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9773648 ↗
• MalfunctionFeb 25, 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 FOR DEFECTIVE INFUSION SETS. SHE STATED THAT THIS IS THE ONLY BATCH THAT SHE HAD ENCOUNTERED ISSUES WITH. HER SETS FELL OFF WHENEVER SHE WOKE UP IN THE MORNING AND SHE HAD TO CHANGE HER INFUSION SETS FOR 3 CONSECUTIVE DAYS BECAUSE THEY JUST FELL OFF FOR NO REASON. SHE WAS UNSURE FOR THE CAUSE OF THE PRODUCT NOT ADHERING. THE PATIENT PREPARED THE SITE BY USING USES ALCOHOL BUT USED TO LET IT DRY FIRST AND SHE DOES NOT PERSPIRE HEAVILY. UPON INVESTIGATION OF THE RETURNED USED DEVICE (1 TUBING), IT SHOWED THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9749112 ↗
• InjuryFeb 5, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT SHE EXPERIENCED VOMITING, ABDOMINAL PAIN, WAS VERY TIRED AND HAD POSITIVE RESULTS IN KETONE TEST. SHE STATED THAT HER PUMP SMELT LIKE INSULIN AND HER SET WAS NOT STICKING CORRECTLY AND THIS MIGHT BE THE REASON WHY HER PUMP WAS NOT DELIVERING INSULIN. REPORTEDLY, THE TAPE DID NOT STICK TO HER SKIN PROPERLY. SUBSEQUENTLY, ON (B)(6) 2020, SHE WAS ADMITTED TO THE HOSPITAL DUE TO DIABETIC KETOACIDOSIS AND HER BLOOD GLUCOSE LEVEL AT THAT TIME WAS 750 MG/DL. DURING HOSPITALIZATION, SHE WAS TREATED FOR HER HIGH BLOOD GLUCOSE LEVELS AND SHE STAYED THERE FOR THREE DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9669211 ↗