Autosoft90™ 1000275Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 05705244014367), received between Dec 21, 2018 and Nov 3, 2020 — classified as 22 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (20 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL DUE TO BENT NEEDLE AND WAS NOT DELIVERING INSULIN. THEREFORE, SHE TRIED TO TREAT IT WITH A BOLUS VIA PUMP, BUT ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO HIGH BLOOD GLUCOSE LEVEL. PATIENT'S HIGHEST BLOOD GLUCOSE LEVEL WAS 750 MG/DL. MOREOVER, THE INFUSION SET HAD BEEN USED FOR 2-3 DAYS. DURING HOSPITALIZATION, SHE RECEIVED FLUIDS OF SALINE, INSULIN AND INTRAVENOUS MEDICATION (DRUG NAME UNKNOWN) AS CORRECTIVE TREATMENT, WHICH RESOLVED THE ISSUE. ON (B)(6) 2020, THE PATIENT WAS RELEASED FROM THE HOSPITAL WITH NO PERMANENT DAMAGE. REPORTEDLY, A DAY BEFORE THIS REPORT, SHE AGAIN FACED A BENT NEEDLE ISSUE AND HER BLOOD GLUCOSE LEVEL WAS 750 MG/DL AT THE TIME OF THIS EVENT. SHE DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. FURTHER, THEY REPLACED THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. 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

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 10776652 ↗
• InjurySep 29, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT HAD THREE BENT/KINKED CANNULAS. AT THE TIME OF THE EVENT, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS MORE THAN 500 MG/DL. IT WAS STATED THAT THE PATIENT HAD INSULIN POOLING AT THE SITE AND THE INSULIN WAS NOT BEING DISTRIBUTED TO HIS BODY WHICH CAUSED HIGH BLOOD GLUCOSE LEVELS BECAUSE OF KINKED/CLOGGED CANNULA. MOREOVER, WHEN THE CANNULA WAS REMOVED IT WAS FOUND THAT THE CANNULA WAS BENT AT THE VERY TIP OF THE CANNULA, WHEN PRESSED ON. FURTHER, HE CHANGED HIS INFUSION, REPLACED THE SITE AND DID A CORRECTION BOLUS VIA PUMP IN ORDER TO ADDRESS THE ISSUE BUT HIS BLOOD GLUCOSE LEVELS STILL WENT UP. ON AN UNKNOWN DATE IN (B)(6) 2020, HE WAS ADMITTED TO THE HOSPITAL AS HE HAD MODERATE KETONES AND HIGH BLOOD GLUCOSE LEVELS. HE WAS ADMINISTERED SOME UNSPECIFIED MEDICATION INTRAVENOUSLY (DRUG NAME UNKNOWN), FLUIDS OF SALINE AND INSULIN WHICH RESOLVED THE ISSUE. AFTER THREE DAYS OF STAY IN THE HOSPITAL, HE WAS RELEASED FROM THE HOSPITAL WITH NO PERMANENT DAMAGE. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF IN

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 10598314 ↗
• InjuryAug 14, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A KINKED CANNULA ISSUE. THE PATIENT'S BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS ABOVE 500 MG/DL WHICH SHE TRIED TO TREAT WITH A CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION. THE INFUSION SET WAS USED FOR LESS THAN A DAY AND THERE WAS NO DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. FURTHER, SHE GENERALLY INSERTED HER SETS ON HER ABDOMEN. SUBSEQUENTLY, ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL AS SHE UNRESPONSIVE AFTER GOING INTO DIABETIC KETOACIDOSIS DUE TO A KINKED CANNULA ISSUE (WHICH WAS FOUND AT THE HOSPITAL). HER HIGHEST BLOOD GLUCOSE LEVEL WAS 775MG/DL. DURING HOSPITALIZATION SHE WAS PLACED ON A VENTILATOR, GIVEN MEDICATION INTRAVENOUSLY (DRUG NAME UNKNOWN), FLUIDS, INSULIN, MAGNESIUM, POTASSIUM, ETC. WHICH RESOLVED THE ISSUE. ON (B)(6) 2020, SHE WAS RELEASED FROM THE HOSPITAL AND SHE REPORTED THAT HER MEMORY IS OFF AND IS NOT THE SAME. MOREOVER, IT WAS MENTIONED THAT THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING IS

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 10406414 ↗
• InjuryMar 4, 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 AND EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. FURTHER, HER HIGHEST BLOOD GLUCOSE LEVEL WAS ABOUT 600 MG/DL, WHICH SHE TRIED TO TREAT WITH A BOLUS, BUT ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO DIABETIC KETOACIDOSIS, WHERE SHE RECEIVED INSULIN DRIP AS CORRECTIVE TREATMENT. MOREOVER, THE INFUSION HAD BEEN USED FOR ONE DAY. CURRENTLY, SHE WAS HOSPITALIZED AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. 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 9784527 ↗
• InjuryJun 21, 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 DUE TO WHICH HE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 540 MG/DL. IT WAS TREATED WITH A BOLUS AND WHEN THAT DID NOT WORK, HE WAS GIVEN AN INJECTION ON THE WAY TO THE EMERGENCY ROOM. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS AT 350 MG/DL WHEN HE ARRIVED AT THE EMERGENCY ROOM. HE ALSO HAD A HIGH LEVEL OF KETONES, WHICH WAS IDENTIFIED AS DANGEROUS BY A HEALTHCARE PROFESSIONAL. AT THE EMERGENCY ROOM, HIS BLOOD WORK WAS TAKEN, INSULIN WAS GIVEN, AND AN UNKNOWN MEDICATION WAS ADMINISTERED THROUGH INTRAVENOUS ROUTE. THE PATIENT SPENT 4-5 HOURS IN THE EMERGENCY ROOM AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL. AT THE HOSPITAL, BLOOD WORK WAS PERFORMED, AND UNSPECIFIED MEDICATION WAS ADMINISTERED THROUGH INTRAVENOUS ROUTE, WHICH RESOLVED THE ISSUE. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE PATIENT SPENT AT LEAST 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 C

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8721254 ↗
• InjuryApr 25, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED A KINKED CANNULA ISSUE. SHE HAD HIGH BLOOD GLUCOSE LEVELS AND EXPERIENCED DIABETIC KETOACIDOSIS WHICH SHE SELF-TREATED WITH A CORRECTION BOLUS BY THE PUMP. HER BLOOD GLUCOSE LEVEL WAS 575 MG/DL, WHEN SHE ARRIVED AT THE EMERGENCY ROOM AND SHE STAYED THERE FOR FEW HOURS. WHEN SHE LEFT FROM THE EMERGENCY ROOM, SHE WAS EXHAUSTED, HAD BRUISED AND BANDAGES AT HER ELBOW AND HER BLOOD GLUCOSE WAS 119 MG/DL. SUBSEQUENTLY, SHE WAS ADMITTED TO THE INTENSIVE CARE UNIT AND IT WAS DISCOVERED AFTER SHE WAS ADMITTED TO THE HOSPITAL THAT HER CANNULA WAS KINKED. HER HIGHEST BLOOD GLUCOSE REPORTED WAS 578 MG/DL. THE PATIENT WAS TREATED WITH INSULIN DRIP AND ANTI-NAUSEA MEDICATION IN THE EMERGENCY ROOM AND DURING HOSPITALIZATION WHICH RESOLVED THE ISSUE. SHE WAS HOSPITALIZED FOR FOUR DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. 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 U

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8547999 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT SHE WAS HOSPITALIZED DUE TO A BENT CANNULA ISSUE. HIGHEST BLOOD GLUCOSE LEVEL REPORTED WAS 770 MG/DL. IN THE HOSPITAL, THE PATIENT RECEIVED MULTIPLE DAILY INJECTIONS AS CORRECTIVE TREATMENT, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR THREE DAYS. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE PATIENT STAYED IN THE HOSPITAL FOR THREE 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 8543409 ↗
• InjuryApr 22, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED BENT CANNULA ISSUE DUE TO WHICH THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 1000 MG/DL AND THE PATIENT HAD LARGE KETONES. THE PATIENT SELF-TREATED BY ADMINISTERING A BOLUS VIA THE PUMP. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE PATIENT RECEIVED AN INSULIN INTRAVENOUS DRIP, WHICH RESOLVED THE ISSUE. 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 8534997 ↗
• InjuryApr 22, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED BENT CANNULA ISSUE AND EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND UPON ARRIVAL, PATIENT'S BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 1000 MG/DL AND HAD SMALL KETONES. WHILE IN THE EMERGENCY ROOM, THE PATIENT WENT INTO DIABETIC KETOACIDOSIS. THE PATIENT STAYED THERE FOR SEVEN HOURS AND UPON LEAVING THE EMERGENCY ROOM, BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 1000 MG/DL AND THE PATIENT'S CONDITION WAS CRITICAL. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE THE PATIENT RECEIVED INTRAVENOUS DRIP, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR FIVE DAYS. THE PATIENT STAYED IN THE HOSPITAL FOR THREE DAYS AND WAS NORMAL UPON RELEASE. 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 8534981 ↗
• InjuryApr 22, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT WHILE SHE WAS TRYING TO ATTACH THE INFUSION SET TO HER BODY, HOWEVER, THE CANNULA WAS BENT AND AS A RESULT SHE WAS HOSPITALIZED. SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE DUE TO SURGERY. SHE WENT TO THE EMERGENCY AND STAYED THERE FOR SEVERAL HOURS. HER BLOOD GLUCOSE LEVEL WHEN SHE ARRIVED AT THE EMERGENCY WAS 674 MG/DL. SHE HAD HIGH KETONE LEVELS AND THE HEALTH CARE PROFESSIONAL IDENTIFIED THE KETONE LEVEL AS DANGEROUS. SHE DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. SHE WAS HOSPITALIZED FOR 3 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 8534609 ↗
• InjuryApr 22, 2019Device Handling Problem; Device Handling Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED ISSUES WITH 5 INFUSION SETS THAT DID NOT STICK WELL. SHE WAS NOT RECEIVING INSULIN DUE TO BENT CANNULA AND WAS SUBSEQUENTLY HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. HER BLOOD GLUCOSE VALUE AT THE TIME OF THE EVENT WAS 243 MG/DL. SHE WAS ADMITTED INTO THE EMERGENCY AND STAYED THERE FOR 5 HOURS. HER BLOOD GLUCOSE LEVEL WHEN SHE ARRIVED AT THE EMERGENCY WAS 527 MG/DL AND 300 MG/DL WHEN SHE LEFT THE EMERGENCY. THE PATIENT HAD KETONES AND THE HEALTH CARE PROFESSIONAL IDENTIFIES THE KETONE LEVEL AS DANGEROUS. THE INFUSION SET HAD BEEN IN USE FOR 1.5 DAYS. THE PATIENT RECEIVED INSULIN DRIP AS THE TREATMENT AND THIS RESOLVED THE ISSUE. SHE WAS HOSPITALIZED FOR 2 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 8534553 ↗
• InjuryApr 16, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT'S INFUSION SITE CANNULA WAS BENT. REPORTEDLY, THE BLOOD GLUCOSE LEVEL WAS 739 MG/DL AND THE PATIENT SELF-TREATED IT WITH A BOLUS VIA PUMP. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED AND RECEIVED INTRAVENOUS INSULIN DRIP AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE PATIENT WAS ADMITTED FOR TWO DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE INFUSION SET WAS USED FOR LESS THAN 24 HOURS. 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 8517026 ↗
• InjuryApr 7, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE SITE WAS COMPROMISED AS THE SITE WAS BENT. HER BLOOD GLUCOSE WAS 325 MG/DL AND HAD MODERATE KETONE LEVELS. SHE SELF-TREATED HERSELF WITH A BOLUS. THE INFUSION HAD BEEN IN USE FOR LESS THAN ONE DAY. THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE (325 MG/DL) AND KETONE LEVELS. PATIENT'S BLOOD GLUCOSE LEVEL WAS 298 MG/DL WHEN LEFT THE EMERGENCY ROOM. THE PATIENT RECEIVED BLOOD WORK AND DRIP VIA INTRAVENOUS ROUTE AS CORRECTIVE TREATMENT. SHE WAS IN THE HOSPITAL FOR MORE THAN THREE DAYS AND WAS STILL IN THE HOSPITAL AT THE TIME OF THIS REPORT. 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 8489911 ↗
• MalfunctionApr 5, 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 TWO INFUSION SITES DETACHED FROM HIS BODY WITHIN 24 HOURS. REPORTEDLY, HIS BLOOD GLUCOSE WAS 448 MG/DL, AT THE TIME OF THIS EVENT. THERE WAS NO DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. THE PATIENT SUCCESSFULLY INSERTED A NEW INFUSION SITE ONTO HIS BODY AND RESUMED INSULIN THERAPY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8486250 ↗
• InjuryMar 27, 2019Loss 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 HER INFUSION SET FELL OFF AND HAD HIGH BLOOD GLUCOSE LEVEL (800S MG/DL). SHE CHECKED HER BLOOD GLUCOSE LEVEL AND INSERTED ANOTHER INFUSION SET AND SELF-TREATED WITH A BOLUS. SHE HAD LOW KETONE LEVELS AND THE HEALTH CARE PROFESSIONAL ASSESSED KETONE LEVELS AS DANGEROUS/LIFE THREATENING. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. THE PATIENT WENT TO EMERGENCY ROOM FOR TEN HOURS WITH HIGH BLOOD GLUCOSE LEVEL (800S MG/DL) AND THEN WAS SUBSEQUENTLY HOSPITALIZED DUE TO DIABETES KETOACIDOSIS. SHE RECEIVED SALINE AND INSULIN AS CORRECTIVE TREATMENT AND THIS RESOLVED THIS ISSUE. THE INFUSION SET WAS IN USE FOR 1-2 DAYS. THE PATIENT WAS HOSPITALIZED FOR SEVEN DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8455114 ↗
• InjuryMar 25, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED HAVING BENT CANNULA ISSUES IN THE PAST WITH 8 INFUSION SETS. THE PATIENT EXPERIENCED DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE ABOVE 600 MG/DL. THE PATIENT SELF-TREATED IT WITH A BOLUS VIA PUMP. SUBSEQUENTLY, SHE WAS HOSPITALIZED AND RECEIVED INSULIN VIA INTRAVENOUS ROUTE, WHICH RESOLVED THE ISSUE. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE INFUSION SET HAD BEEN IN USE FOR APPROXIMATELY ONE DAY. THE PATIENT STAYED IN THE HOSPITAL FOR TWO 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 8447376 ↗
• InjuryMar 22, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT SHE HAD MULTIPLE BENT CANNULAS (APPROX. 8 INFUSION SETS) AND DIABETIC KETOACIDOSIS WHICH LEAD TO HOSPITALIZATIONS. THE PATIENT TOOK OUT HER SITE, AS SHE WAS NOT RECEIVING INSULIN DUE TO THE KINKED CANNULA. SHE DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. HER BLOOD GLUCOSE LEVEL WAS APPROXIMATELY BETWEEN 700-800 MG/DL AT THE TIME OF EVENT AND SELF-TREATED HERSELF WITH AN INJECTION OF LANTUS. SHE HAD KETONE LEVELS AND THE HEALTH CARE PROFESSIONAL ASSESSED KETONE LEVEL AS DANGEROUS. DURING HOSPITALIZATION, SHE WAS TREATED WITH WATER, IV FLUIDS AND INJECTIONS OF INSULIN AND THE TREATMENT RESOLVED THE ISSUE. THE INFUSION HAD BEEN IN USE FOR TWO DAYS OR LESS. SHE WAS HOSPITALIZED FOR APPROXIMATELY 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 8443193 ↗
• InjuryFeb 14, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED BENT CANNULA ISSUES THAT LED TO AN INCREASE IN PATIENT'S BLOOD GLUCOSE LEVEL. HIGHEST BLOOD GLUCOSE LEVEL WAS REPORTED TO BE 600 MG/DL THAT WAS TREATED WITH A CORRECTION BOLUS. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED AND RECEIVED INTRAVENOUS INSULIN DRIP, WHICH RESOLVED THE ISSUE. REPORTEDLY, THE PATIENT USED THE INFUSION SET FOR TWO 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 8338227 ↗
• InjuryFeb 7, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED SEVERAL BENT CANNULA ISSUES DUE TO WHICH THE PATIENT EXPERIENCED DIABETIC KETOACIDOSIS, HIGH BLOOD GLUCOSE LEVEL AND HIGH LEVEL OF KETONES THAT WAS IDENTIFIED TO BE DANGEROUS/LIFE THREATENING BY HEALTH CARE PROFESSIONAL. AT THE TIME OF THIS EVENT, PATIENT'S HIGHEST BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL. THE PATIENT DID BOLUS USING THE PUMP AND WAS THEN ADMITTED TO THE HOSPITAL. THE PATIENT RECEIVED INSULIN INTRAVENOUSLY AND A POTASSIUM DRIP IN THE HOSPITAL, WHICH RESOLVED THE ISSUE. THE INFUSION HAD BEEN IN USE FOR LESS THAN A DAY. THERE WAS NO DAMAGE NOTICED WHEN THE PACKAGE WAS FIRST OPENED. THE PATIENT WAS HOSPITALIZED FOR TWO 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 8314215 ↗
• InjuryJan 28, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT STATED ISSUES WITH INFUSION SET IN THE FORM OF BENT CANNULA AND HE ALSO DEVELOPED FLU. DUE TO HIGH BLOOD GLUCOSE (WHICH WAS IN 400S MG/DL) AND FLU, THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WHERE THE STAY WAS 5 HOURS. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS WITH KETONE LEVEL AS DANGEROUS/LIFE THREATENING AS ASSESSED BY HEALTH CARE PROFESSIONAL AND WAS GIVEN INTRAVENOUS INSULIN INJECTIONS AS CORRECTIVE TREATMENT. SUBSEQUENTLY, THE PATIENT LEFT THE EMERGENCY ROOM WITH BLOOD GLUCOSE LEVEL STILL IN 400S MG/DL AND WAS FEELING NAUSEOUS AND WEAK LEADING TO FURTHER ADMISSION IN THE HOSPITAL. THE PATIENT ALSO RECEIVED PREVENTIVE TREATMENT FOR BLOT CLOT. REPORTEDLY, THE PATIENT HAD USED THE INFUSION SET FOR ONE DAY AND WAS HOSPITALIZED FOR THREE 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 8280655 ↗
• InjuryJan 28, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT STATED THAT THE CANNULA WAS BENT AT AN ANGLE OF 90 DEGREE. PRIOR TO HOSPITALIZATION, THE CONTINUOUS GLUCOSE MONITORING READINGS WERE IN 300S MG/DL. THE PATIENT SELF-TREATED WITH SEVERAL BOLUSES. THE PATIENT WAS TAKEN TO THE EMERGENCY, WHERE THE PATIENT STAYED FOR 1 DAY AND DURING THE STAY, THE PATIENT EXPERIENCED NAUSEA AND VOMITING. WHEN THE PATIENT LEFT EMERGENCY, IT FELT WEAKNESS. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND WAS DIAGNOSED DIABETIC KETOACIDOSIS. THE PATIENT WAS TREATED WITH INSULIN DRIP AND GOT ARTERIAL BLOOD GAS TESTS DONE EVERY HOUR WHICH RESOLVED THE ISSUE. THE HEALTH CARE PROFESSIONAL IDENTIFIED THE KETONE LEVEL AS DANGEROUS/LIFE THREATENING. THE INFUSION SET WAS USED FOR 3 DAYS. THE PATIENT WAS HOSPITALIZED FOR 3 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 8280559 ↗
• InjuryJan 25, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED A BENT CANNULA AND HAD HIGH BLOOD GLUCOSE (581 MG/DL) AND DIABETIC KETOACIDOSIS. THE PATIENT HAD BEEN USING MULTIPLE DAILY INJECTIONS FOR HIGH BLOOD GLUCOSE. THE PATIENT REPORTED INSULIN WAS NOT COMING OUT OF THE CANNULA BECAUSE IT WAS BENT, AND PATIENT FELL AND WAS HIT ON THE HEAD. THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL. THE PATIENT HAD KETONES BUT WAS NOT LIFE THREATENING AS PER HEALTH CARE PROFESSIONAL. THE PATIENT WAS USING THE SAME CARTRIDGE AND INFUSION SET WAS STILL CONNECTED TO THE PUMP AND PATIENT HAD INSULIN DRIP AS A CORRECTIVE TREATMENT IN THE HOSPITAL WHICH RESOLVED THE ISSUE. THE PATIENT WAS HOSPITALIZED FOR 2 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 8277205 ↗
• InjuryJan 23, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED BENT CANNULA ISSUE AND EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 527 MG/DL AND SELF-TREATED WITH A BOLUS. SUBSEQUENTLY, THE PATIENT WENT TO THE EMERGENCY WITH HIGH BLOOD GLUCOSE LEVEL BETWEEN 422-477 MG/DL WITH HIGH KETONES LEVEL. THE PATIENT STAYED IN EMERGENCY FOR FEW HOURS AND THE PATIENT LEFT EMERGENCY, THE BLOOD GLUCOSE LEVEL WAS 420 MG/DL. THE HEALTHCARE PROFESSIONAL ASSESSED KETONE LEVEL AS DANGEROUS/LIFE THREATENING. THE INFUSION SET WAS IN USE FOR ONE AND HALF DAY. THE PATIENT RECEIVED INSULIN DRIP AS CORRECTIVE TREATMENT AND THE ISSUE WAS RESOLVED. THE PATIENT WAS HOSPITALIZED FOR TWO 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 8270038 ↗
• MalfunctionDec 21, 2018Detachment 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 HIS INFUSION SET TUBING (ONLY THE PATIENT LINE) DISCONNECTED FROM THE INFUSION SET SITE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8188532 ↗