Mio® MMT-923Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 05705244007697), received between Dec 17, 2018 and Jul 7, 2024 — classified as 21 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (33 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 54 reports, in the reporter's own words as published by the FDA.

• 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 PATIENT FACED SEVERE HYPERGLYCEMIA EVENT ON 07-JUN-2018. THE BLOOD GLUCOSE LEVEL WAS GREATER THAN 600 MG/DL AT THE TIME OF EVENT WITH THE PRESENCE OF KETONES. THE SYMPTOMS OBSERVED WAS VOMITING. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 19686471 ↗
• MalfunctionFeb 15, 2023Detachment 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, IT WAS REPORTED THAT WHILE THE PATIENT WAS SLEEPING, THE PINK PLASTIC PART SEPARATED FROM THE CORD AND HER SITE PULLED OUT, SHE WAS TOSSING AND TURNING MORE IN THE PAST MONTH AND THE CORD DETACH FROM THE QUICK RELEASE. MOREOVER, THE ENTIRE SITE PULLED OUT AT ONE POINT BOTH THINGS HAPPENED TO ONE SITE THIS MORNING WITH PATIENT'S BLOOD GLUCOSE LEVEL OF 153 MG/DL. WHEN THIS ISSUE OCCURRED ONE TIME, HER BLOOD GLUCOSE LEVEL RANGED BETWEEN 260-280 MG/DL. THE SITE LOCATION WAS PATIENT'S BUTTOCK AND THE PUMP WAS ATTACHED TO THE WAIST BAND. THE INFUSION SET HAD BEEN USED FOR AT LEAST A DAY. REPORTEDLY, THE INFUSIONS WERE STORED IN A DRAWER AND IN PURSE. THE PATIENT WAS UNSURE WHETHER THERE WAS ANY 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 16377731 ↗
• InjuryJul 30, 2021Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2021, THE PATIENT REPORTED THAT HER LAST TWO INFUSION SETS HAVE HAD BENT CANNULAS. REPORTEDLY, ON (B)(6) 2021 AT 1:00 PM, SHE WAS ADMITTED TO THE HOSPITAL DUE TO BLOOD GLUCOSE LEVEL OF 780 MG/DL AND DIABETIC KETOACIDOSIS. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 271 MG/DL AND EXPERIENCED DIABETIC KETOACIDOSIS. SHE WAS TREATED WITH SOME UNSPECIFIED DRUG INTRAVENOUSLY (DRUG NAME UNKNOWN) AND WAS CURRENTLY IN THE HOSPITAL (AT THE TIME OF THIS REPORT). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 12251451 ↗
• MalfunctionApr 12, 2021Detachment 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 12-MAY-2021: FOLLOW UP INFORMATION WAS SUBMITTED TO UPDATE THE LOT NUMBER, EXPIRY DATE AND AWARENESS DATE. MOREOVER, THE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (2 SETS) SHOWED THAT ALL THE TEST RESULTS WERE WITHIN SPECIFICATION. BASED ON THE RESULT: MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, 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) 2021, IT WAS REPORTED THAT WHILE UNWINDING THE INFUSION SET'S TUBING BEFORE INSERTION, IT ACCIDENTLY PULLED OUT THE SET AT THE TUBING CONNECTOR AND THIS ISSUE OCCURRED A COUPLE OF WEEKS AGO. CURRENTLY, PATIENT'S BLOOD GLUCOSE LEVEL WAS 152 MG/DL. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11647334 ↗
• InjuryJan 8, 2021Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND DIABETIC KETOACIDOSIS DUE TO A KINKED CANNULA BUT THERE WAS NO ALARM FROM THE PUMP. CONSEQUENTLY, ON (B)(6) 2020, SHE WAS ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE LEVEL OF 30 MMOL/L, WHERE INTRAVENOUS INSULIN DRIP WAS ADMINISTERED AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE PATIENT WAS HOSPITALIZED FOR FIVE DAYS. 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 11139055 ↗
• MalfunctionAug 10, 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 IN THREE- FOUR SETS OUT OF ONE BOX, THE INFUSION SET'S TUBING HAD DISCONNECTED AT THE QUICK RELEASE. 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 Known Impact Or Consequence To Patient

  MAUDE report 10384035 ↗
• MalfunctionJul 3, 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 INFUSION SET'S TUBING DETACHED AT THE QUICK RELEASE AND THE PATIENT NOTICED INSULIN OUT OF THE TUBING ABOUT TWELVE HOURS AFTER CHANGING THE SET. THIS ISSUE OCCURRED WITH TWO SETS. MOREOVER, THE CATHETER WAS IN USE FOR 2-3 DAYS AND THE PATIENT HAD REDNESS ON THE SKIN AS A SIGN OF SKIN INFECTION FOR OVER ONE WEEK. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Inflammation

  MAUDE report 10228753 ↗
• MalfunctionJun 9, 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 WHEN THE PATIENT WOKE UP, THE INFUSION SET'S TUBING DISCONNECTED FROM THE QUICK RELEASE SECTION. SHE ALSO STATED THAT QUICK RELEASE CLIP WAS STILL ATTACHED TO THE SECURED CANNULA, BUT THE TUBING CAME AWAY FROM THAT CLIP. MOREOVER, THE PATIENT DID NOT FEEL IT WAS PULLED OFF OR ANYTHING SHE JUST WANTED TO REPORT IT. NO FURTHER INFORMATION AVAILABLE

  Patient problems: Hyperglycemia

  MAUDE report 10132092 ↗
• MalfunctionFeb 24, 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, IT WAS REPORTED THAT A DAY BEFORE THIS REPORT, THE PATIENT'S INFUSION SET'S TUBING HAD DETACHED FROM THE TUBING CONNECTOR WHILE SHE WAS IN THE MIDDLE OF REPLACING (ON THE PROCESS OF INSERTING) THE INFUSION SET. THE SITE LOCATION WAS AT HER LEFT SIDE AND THE PUMP WAS LOCATED ON THE RIGHT SIDE. REPORTEDLY, THE INFUSIONS WERE STORED IN THE 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: No Known Impact Or Consequence To Patient

  MAUDE report 9743467 ↗
• InjuryJan 27, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NAUSEA, VOMITING, ABDOMINAL PAIN, DIFFICULTY IN BREATHING AND HAD POSITIVE RESULTS FOR KETONE LEVELS. FURTHER, PATIENT'S BLOOD GLUCOSE LEVEL INCREASED TO 600 MG/DL DUE TO BENT CANNULA. THEREFORE, ON (B)(6) 2019, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT DUE TO HIGH BLOOD GLUCOSE LEVEL (600 MG/DL), WHERE THE PATIENT RECEIVED INSULIN DRIPS AS CORRECTIVE TREATMENT. MOREOVER, THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE INFUSION HAD BEEN USED FOR ONE DAY. THE PATIENT WAS ADMITTED FOR THREE DAYS IN 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 9630832 ↗
• InjuryDec 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT A CHILD PATIENT HAD VOMITING, WAS SCREAMING IN PAIN AND EXPERIENCED DIABETIC KETOACIDOSIS DUE TO BENT CANNULA AT INFUSION SITE. REPORTEDLY, THE PATIENT DID NOT HAVE A NORMAL EATING SCHEDULE. THEREFORE, THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2019 AND ON (B)(6) 2019, WITH BLOOD GLUCOSE LEVEL IN 500'S MG/DL, DUE TO CRIMPED CANNULA, AS IT WAS CURLED INTO A SQUARISH WHICH THEY NOTICED WHEN THEY REMOVED THE INFUSION SET. THE SITE LOCATION WAS THE PATIENT'S ABDOMEN. DURING HOSPITALIZATION, THE PATIENT WAS PUT ON AN INTRAVENOUS DRIP (ZOFRAN). 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 9514819 ↗
• InjuryDec 17, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT, ON (B)(6) 2016, THE DAUGHTER FOUND THE PATIENT UNCONSCIOUS AND CALLED THE PARAMEDICS. THEREFORE, ON THE SAME DAY AT 01:00 PM, THE PATIENT WAS ADMITTED IN THE HOSPITAL BY THE PARAMEDICS FOR DIABETIC KETOACIDOSIS AND BLOOD GLUCOSE LEVEL OF 1300 MG/DL. WHEN THE INFUSION SET WAS REMOVED IT WAS FOUND THAT THE CANNULA WAS BENT. PREVIOUSLY, SHE CHANGED HER INFUSION ON (B)(6) 2016 AND IT HAD BEEN IN USE FOR THREE DAYS. REPORTEDLY, THE SITE LOCATION WAS HER ABDOMEN. DURING HOSPITALIZATION, SHE RECEIVED INTRAVENOUS DRIP WITH SALINE, INSULIN SHOTS AND POTASSIUM PILLS. THE PATIENT WAS HOSPITALIZED FOR FOUR DAYS. 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 9478941 ↗
• InjuryDec 16, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S FATHER REPORTED THAT THE PATIENT WAS HAVING ISSUES WITH INFUSION SET AS SHE EXPERIENCED A BENT CANNULA DUE TO WHICH SHE HAD HIGH BLOOD GLUCOSE LEVEL (OVER 600 MG/DL) AND STREP THROAT. ON (B)(6) 2019, SHE WAS ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE LEVEL OVER 600 MG/DL AND DIABETIC KETOACIDOSIS (HIGH KETONE LEVELS). DURING HOSPITALIZATION, SHE RECEIVED INTRAVENOUS MEDICATION (DRUG NAME UNKNOWN). THE PATIENT'S SITE LOCATION WAS AT HER LEG OR BUTTOCK AND THE INFUSION HAD BEEN IN USE FOR ONE DAY. 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 9472077 ↗
• MalfunctionDec 3, 2019Detachment 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 HE HAD HIGH BLOOD GLUCOSE LEVEL OF 378 MG/DL WHICH HE TRIED TO TREAT WITH A BOLUS, BUT IT DID NOT BRING IT DOWN. FURTHER, HE NOTICED THAT THE INFUSION SET'S TUBING WAS DISCONNECTED AT THE QUICK RELEASE, SO HE NEEDED TO REPLACE HIS SET AND RESERVOIR. AT THE TIME OF THE INCIDENT, HIS BLOOD GLUCOSE LEVEL WAS 372 MG/DL. UPON INVESTIGATION OF THE RETURNED USED DEVICE (1 SET), IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR (WAS NOT ASSEMBLED PROPERLY). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 9400144 ↗
• MalfunctionNov 13, 2019Detachment 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 CAME APART AT THE CANNULA, WHILE THE PATIENT WAS STANDING. THE SITE LOCATION WAS AT RIGHT SIDE OF THE ABDOMEN, NEXT TO THE BELLY BUTTON AND THE PUMP WAS ON THE LEFT SIDE OF THE ABDOMEN. THE INFUSION HAD BEEN IN USE FOR 3-4 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 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 9314769 ↗
• InjuryNov 1, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED BY THE PATIENT'S MOTHER THAT HER DAUGHTER HAD NAUSEA, VOMITING, ABDOMINAL PAIN AND DIFFICULTY IN BREATHING. FURTHER, HER BLOOD GLUCOSE LEVEL WAS 618 MG/DL WHICH THEY TRIED TO TREAT WITH THE BOLUS. ON (B)(6) 2019, THE INFUSION WAS CHANGED. SUBSEQUENTLY, ON (B)(6) 2019 AT 5:00 AM, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO RAISED BLOOD GLUCOSE LEVELS OF 618 MG/DL. DURING HOSPITALIZATION, SHE HAD RECEIVED INSULIN DRIP AS CORRECTIVE TREATMENT. IT WAS STATED THAT WHEN SHE REMOVED THE SET, IT WAS FOUND TO BE BENT. FURTHERMORE, IT WAS MENTIONED THAT SHE WAS GOING TO INSERT A NEW SET INTO THE BODY. 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 9265247 ↗
• MalfunctionOct 30, 2019Detachment 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 ON (B)(6) 2018, WHEN SHE WOKE UP IN THE MORNING, HER INFUSION SET'S TUBING DETACHED FROM THE TUBING CONNECTOR, WHILE SLEEPING. THIS ISSUE OCCURRED TWICE. THE SITE LOCATION WAS AT THE PATIENT'S RIGHT HIP AND THE PUMP WAS LAID ON THE BED. THE INFUSION HAD BEEN IN USE FOR A DAY. REPORTEDLY, THE INFUSIONS WERE STORED ON THE DRESSER, IN PATIENT'S ROOM. 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 INVESTIGATION PERFORMED ON THE RETURNED USED DEVICE (3 TUBING'S), IT WAS FOUND THAT THE TUBING'S WERE DETACHED FROM THE TUBING CONNECTORS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9254149 ↗
• InjuryOct 1, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. A (B)(6) PATIENT REPORTED MULTIPLE BENT CANNULA ISSUES, AS THE INSULIN WAS FLOWING FREELY WITH THE PUMP AND DID MULTIPLE SET CHANGES, BUT STILL NOTHING WAS WORKING. MOREOVER, WHEN THE SET WAS CHANGED, THE CANNULA WAS FOUND BENT. HOWEVER, AFTER THE PATIENT WOKE UP FROM A NAP, TRYING NOT TO VOMIT BUT EXPERIENCED DIABETIC KETOACIDOSIS DUE TO ANOTHER BENT SITE. ON (B)(6) 2019 (FRIDAY NIGHT), THE PATIENT WAS ADMITTED IN THE INTENSIVE CARE UNIT, IN FULL BLOWN DIABETIC KETOACIDOSIS. DURING HOSPITALIZATION, THE PATIENT WAS PUT ON AN INSULIN DRIP, INTRAVENOUS FLUIDS (DRUG NAME UNKNOWN), HAD COUNTLESS BLOOD INVESTIGATIONS, THREE INTRAVENOUS, AND MORE BLOOD GLUCOSE TESTS. FURTHER, THE PATIENT WAS DOING WELL FINALLY, ENOUGH TO GO BACK ON THE PUMP ON THE DAY OF THIS REPORT, DATED (B)(6) 2019) AND ATE FOR THE FIRST TIME SINCE EARLY FRIDAY AFTER INSERTING A NEW SET AND DID A BOLUS. REPORTEDLY, THE PATIENT WAS IN THE INTENSIVE CARE UNIT FOR THREE DAYS AND WAS STILL ADMITTED AT THE TIME OF THIS REPORT ((B)(6) 2019). UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING C

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9138403 ↗
• MalfunctionSep 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING DETACHED. MOREOVER, THE PATIENT CHECKS THE TUBING PRIOR TO INSERTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9127376 ↗
• MalfunctionSep 4, 2019Detachment 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 28-NOV-2019: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 SET) SHOWED THAT ALL THE TEST RESULT WAS 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. THE PATIENT REPORTED THAT WHILE SLEEPING IN THE MIDDLE OF NIGHT, THE INFUSION SET'S TUBING GOT RIPPED OUT AT THE QUICK RELEASE AND THE INFUSION SET WAS NO LONGER CONNECTED TO HER BODY. THE SITE OF LOCATION WAS HER LEFT THIGH AND THE PUMP WAS WORN ON THE WAIST BAND. THE INFUSION HAD BEEN IN USE FOR TWO DAYS AND THEY WERE STORED AT ROOM TEMPERATURE. THERE WAS 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 8958871 ↗
• InjuryAug 28, 2019Material Twisted/Bent; Material Twisted/Bent

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2019, IT WAS REPORTED BY A NURSE THAT SHE HAS A PATIENT WHO WAS ADMITTED TO THE HOSPITAL, IN THE AFTERNOON OF (B)(6) 2019, DUE TO KINKED CANNULA, DIABETIC KETOACIDOSIS, GASTRIC PAINS AND WORE A PUMP. THE NURSE NOTICED THAT THE PATIENT'S CANNULA WAS KINKED UPON REMOVAL WHICH LED TO INCREASED BLOOD GLUCOSE LEVELS. SHE RECEIVED SOME UNSPECIFIED MEDICATIONS TO CORRECT THE INSULIN. 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 8939124 ↗
• MalfunctionAug 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 08-NOV-2019: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 SET) SHOWED THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. BASED ON THE RESULT: METHOD, RESULT AND CONCLUSION CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING CAME OUT FROM THE QUICK RELEASE WHILE SHE WAS SLEEPING AT NIGHT. REPORTEDLY, THE ACTUAL RELEASE REMAINED ATTACHED TO THE SITE, BUT THE TUBING FELL OUT. WHEN SHE WOKE UP, HER BLOOD GLUCOSE LEVEL WAS 146 MG/DL, ALTHOUGH SHE HAD BEEN RUNNING A LOT LOWER. THEREAFTER, SHE REACHED OUT TO HER TRAINER WHO INFORMED HER TO TAKE IT OFF. THE SITE LOCATION WAS UPPER THIGH AND THE PUMP WAS ON THE SAME SIDE AS THE SITE LOCATED ON HER WAISTBAND. THE INFUSION WAS USED FOR LESS THAN 4 HOURS AND THEY WERE STORED ON THE DESK IN HER GUEST ROOM. 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 Known Impact Or Consequence To Patient

  MAUDE report 8919419 ↗
• MalfunctionAug 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING CAME APART FROM THE SITE ITSELF AS IT GOT CAUGHT WHILE SHE WAS REMOVING HER GARMENTS, WHICH SHE STATED WAS HER OWN ERROR. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS REPORTED TO BE 100 MG/DL. THE SITE LOCATION WAS PATIENT'S THIGH AND THE PUMP WAS LOCATED ON THE BELT. REPORTEDLY, THE INFUSION HAD BEEN IN USE FOR HALF A DAY AND 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 THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8887019 ↗
• InjuryAug 6, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED BENT CANNULA ISSUE TWICE AND EXPERIENCED DIABETIC KETOACIDOSIS. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT. THE PATIENT RECEIVED NO ALARMS AND BLOOD GLUCOSE LEVEL WAS REPORTED TO BE 344 MG/DL. THE SITE LOCATION WAS RIGHT SIDE OF PATIENT'S ABDOMEN AND THE INFUSION SET HAD BEEN IN USE FOR ONE DAY. 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 8862972 ↗
• MalfunctionAug 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 24-FEB-2020: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 SET AND 1 TUBING), 2 DEVICES SHOWED THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. BASED ON THE RESULT: METHOD, RESULT AND CONCLUSION CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT TWO INFUSION SET'S TUBING CAME APART AT THE ABDOMEN. THE PUMP WAS LOCATED ON THE ABDOMEN. THE INFUSION HAD BEEN IN USE FOR LESS THAN A 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 THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8858602 ↗