Autosoft90™ 1000273Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 05705244014305), received between Jan 28, 2019 and Jun 15, 2021 — classified as 42 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (35 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 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 LEVELS AND DIABETIC KETOACIDOSIS. FURTHER, SHE ATTEMPTED TO MANUALLY INJECT (MAINLY BOLUS DELIVERY OF LESS THAN 3 UNITS) WHEN SHE NOTICED SHE WAS GOING INTO DIABETIC KETOACIDOSIS. THE INFUSION SET HAD BEEN USED FOR ONE DAY. SUBSEQUENTLY, ON (B)(6) 2021, SHE WENT TO THE EMERGENCY ROOM, WITH BLOOD GLUCOSE LEVEL OF MORE THAN 30 MMOL/L WHICH WAS DUE TO A KINKED CANNULA, WHERE SHE WAS TREATED FOR HER DIABETIC KETOACIDOSIS (AS SHE SHAD KETONES) THROUGH FLUID DRIP INTRAVENOUSLY WHILE BEING ADMITTED INTO HOSPITAL. SHE STAYED IN THE EMERGENCY ROOM FOR A SHORT PERIOD OF TIME (WITHIN AN HOUR) AND LEFT FROM THERE WITH BLOOD GLUCOSE LEVEL AROUND 10 MMOL/L. CONSEQUENTLY, ON THE SAME DAY ((B)(6) 2021), HER BLOOD GLUCOSE LEVEL HAD DECREASED SIGNIFICANTLY, BUT SHE WAS ADMITTED TO THE HOSPITAL AS SHE WAS STILL UNWELL. DURING HOSPITALIZATION, SHE RECEIVED DRIP INTRAVENOUSLY AND WAS MANUALLY INJECTING AS CORRECTIVE TREATMENT INSTRUCTED FROM HER HEALTH CARE PROFESSIONAL WHICH RESOLVED THE ISSUE. CURRENTLY, THE PATIENT WAS STILL ADMITTED IN THE HOSPITAL. PREVIOUSLY, ON (B)(6) 202

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 11997681 ↗
• InjuryJun 15, 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 LEVELS AND DIABETIC KETOACIDOSIS. FURTHER, SHE ATTEMPTED TO MANUALLY INJECT WHEN SHE NOTICED SHE WAS GOING INTO DIABETIC KETOACIDOSIS. THE INFUSION SET HAD BEEN USED FOR THREE DAYS. SUBSEQUENTLY, ON (B)(6) 2021, SHE WENT TO THE EMERGENCY ROOM, WITH BLOOD GLUCOSE LEVEL OF MORE THAN 40 MMOL/L WHICH WAS DUE TO A KINKED CANNULA, WHERE SHE WAS TREATED FOR HER DIABETIC KETOACIDOSIS (AS SHE SHAD KETONES) THROUGH INSULIN INFUSION, POTASSIUM AND GLUCOSE WHILE BEING ADMITTED INTO HOSPITAL. SHE STAYED IN THE EMERGENCY ROOM FOR A FEW HOURS AND LEFT FROM THERE WITH BLOOD GLUCOSE LEVELS BETWEEN 8 AND 14 MMOL/L. CONSEQUENTLY, ON THE SAME DAY ((B)(6) 2021), SHE WAS ADMITTED TO THE HOSPITAL AS SHE WAS STILL UNWELL. DURING HOSPITALIZATION, SHE WAS ADMINISTERED INSULIN INFUSION, GLUCOSE AND POTASSIUM AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. ON (B)(6) 2021, SHE 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 INSERTION SITES AND INFU

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 11997557 ↗
• InjurySep 4, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2019, THE PATIENT HAD MULTIPLE BENT CANNULA ISSUE AND EXPERIENCED HIGH BLOOD GLUCOSE. REPORTEDLY, INFUSION SET WAS USED FOR LESS THAN A DAY. SHE HAD VOMITING AND HIGH BLOOD GLUCOSE LEVEL (HER CONTINUOUS GLUCOSE MONITORING INDICATED IT AS 400 MG/DL OR ABOVE, BUT SHE DID NOT CONFIRM THE VALUE WITH HER METER), WHICH SHE TRIED TO TREAT WITH THE PUMP AND BY CHANGING HER SUPPLIES. ON (B)(6) 2019, SHE WAS TRANSPORTED BY THE AMBULANCE TO THE EMERGENCY ROOM AND UPON ARRIVAL, HER BLOOD GLUCOSE LEVEL WAS 650 MG/DL AND WHEN SHE REMOVED THE INFUSION SET THERE, SHE OBSERVED THAT THE CANNULA WAS BENT. MOREOVER, HER KETONE LEVEL WAS ASSESSED DANGEROUS/LIFE THREATENING BY HEALTH CARE PROFESSIONAL. SHE STAYED THERE FOR A FEW HOURS AND RECEIVED SOME UNSPECIFIED FLUIDS INTRAVENOUSLY. SHE LEFT THE EMERGENCY ROOM, WITH BLOOD GLUCOSE LEVEL OF 650 MG/DL AND WAS SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT FOR DIABETIC KETOACIDOSIS. SHE RECEIVED SOME UNSPECIFIED INTRAVENOUS FLUIDS, LANTUS AND FAST ACTING INSULIN FOR FOOD BOLUSES, AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. ON (B)(6) 2019, SHE WAS DISCHARGED AND HAD

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8958999 ↗
• InjuryAug 20, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THEREFORE, THE PATIENT'S MOTHER CHANGED HER SON'S INFUSION SET AND NOTICED THAT THE CANNULA WAS KINKED. ON THE SAME DAY, THE PATIENT RECEIVED INCOMPLETE BOLUS ALERT. ON (B)(6) 2019, THE PATIENT CONTINUED EXPERIENCING HIGH BLOOD GLUCOSE LEVEL AND RECEIVED INCOMPLETE TEMPORARY BASAL RATE ALERT. THE PATIENT'S MOTHER TRIED TO TREAT IT BY GIVING CORRECTION THROUGH THE PUMP. SUBSEQUENTLY, THE PATIENT WENT TO THE EMERGENCY ROOM WITH BLOOD GLUCOSE LEVEL AT 403 MG/DL. IN THE EMERGENCY ROOM, HE WAS PUT ON INTRAVENOUS FLUIDS AND RECEIVED SUBCUTANEOUS INJECTIONS AS CORRECTIVE TREATMENT. HE HAD LARGE AMOUNT OF KETONE AND ITS LEVEL WAS ASSESSED AS DANGEROUS/LIFE THREATENING BY A HEALTH CARE PROFESSIONAL. AFTER SPENDING A FEW HOURS IN THE EMERGENCY ROOM, HE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS ON THE SAME DAY WHERE HE RECEIVED INTRAVENOUS FLUIDS AND INJECTIONS, WHICH RESOLVED THE ISSUE. THE INFUSION HAD BEEN IN USE FOR LESS THAN A DAY AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. AT THE HOSPITAL, THE PATIENT'S MOTHER CHANGED OUT

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8909715 ↗
• InjuryJun 28, 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 ON (B)(6) 2019 DUE TO WHICH SHE CHANGED THE INFUSION SET AND THE CARTRIDGE. SHE GAVE HERSELF A MANUAL INJECTION WITH AN INSULIN PEN. SHE WAS NOT SURE IF INSULIN PEN WAS EXPIRED BUT KNEW THAT THERE WAS NOT ENOUGH INSULIN IN PEN TO LOWER HER BLOOD GLUCOSE LEVEL. THEREAFTER, THE SECOND CANNULA WAS ALSO FOUND TO BE BENT. THE PATIENT WAS TESTED FOR KETONES IN THE NIGHT OF (B)(6) 2019 AND HER LEVEL WAS NOT IDENTIFIED TO BE DANGEROUS/LIFE THREATENING BY A HEALTHCARE PROFESSIONAL. THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL DUE TO TWO BENT CANNULAS AND SINCE SHE WAS NOT RECEIVING INSULIN FROM (B)(6) 2019 MORNING (OVER 12 HOURS). SUBSEQUENTLY, SHE WENT TO THE EMERGENCY ROOM WITH BLOOD GLUCOSE LEVEL OVER 500 MG/DL AND STAYED THERE FOR 30 MINUTES. WHEN SHE LEFT THE EMERGENCY ROOM, HER BLOOD GLUCOSE LEVEL WAS HIGH REPORTED TO BE OVER 600 MG/DL AND SHE WAS DELIRIOUS. THEN, SHE WAS ADMITTED TO THE INTENSIVE CARE UNIT ON (B)(6) 2019, WHERE SHE RECEIVED FLUIDS THROUGH INTRAVENOUS ROUTE AND MANUAL INJECTIONS, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN U

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8743284 ↗
• MalfunctionJun 28, 2019Detachment 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 ONE OF THE INFUSION SETS, THE TUBING COMPLETELY DISCONNECTED FROM THE PLASTIC PORTION WHERE THE PIECE CONNECTED TO THE SITE. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 355 MG/DL AT THE TIME OF THIS EVENT. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8743089 ↗
• InjuryJun 17, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT EXPERIENCED DIABETIC KETOACIDOSIS AND HIGHEST BLOOD GLUCOSE LEVEL REPORTED WAS 700 MG/DL. THE PATIENT TRIED TO SELF-TREAT BY DELIVERING INSULIN VIA PUMP BUT BLOOD GLUCOSE LEVEL REMAINED HIGH. SUBSEQUENTLY, HE WAS HOSPITALIZED AND UPON ARRIVAL AT THE HOSPITAL, THE CANNULA WAS FOUND TO BE KINKED. THE PATIENT RECEIVED INSULIN DRIPS AND FLUIDS VIA INTRAVENOUS ROUTE, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR THREE DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. 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 8702757 ↗
• InjuryJun 10, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL (ABOVE 500 MG/DL), WHICH SHE TRIED TO SELF-TREAT WITH A BOLUS VIA PUMP. SHE HAD RECEIVED HIGH BLOOD GLUCOSE ALERTS AND HER HIGHEST BLOOD GLUCOSE LEVEL REPORTED WAS ABOVE 533 MG/DL. SUBSEQUENTLY, SHE WAS HOSPITALIZED WHERE SHE RECEIVED INSULIN DRIP AND UNSPECIFIED MEDICATION VIA INTRAVENOUS ROUTE, WHICH RESOLVED THE ISSUE. THE PATIENT HAD A BENT CANNULA WHEN THE SITE WAS REMOVED FROM HER BODY. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT AND THE INFUSION HAD BEEN IN USE FOR LESS THAN ONE DAY. SHE WAS HOSPITALIZED FOR TWO DAYS AND WAS ABLE TO RESUME INSULIN THERAPY, THEREAFTER. 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 8682118 ↗
• InjuryJun 10, 2019Material Twisted/Bent; Material Twisted/Bent

  (B)(4). EVENT OCCURRED IN THE UNITED STATES THE PATIENT FACED BENT CANNULA ISSUES THAT CAUSED HIGH BLOOD GLUCOSE LEVEL, REPORTED TO BE MORE THAN 500 MG/DL. THE PATIENT WENT TO THE EMERGENCY ROOM WHERE THE PATIENT WENT THROUGH BLOOD TESTS, RECEIVED SHOTS AND UNSPECIFIED MEDICATION THROUGH INTRAVENOUS ROUTE. THE PATIENT STAYED THERE FOR 12 HOURS AND LEFT THE EMERGENCY ROOM WITH BLOOD GLUCOSE LEVEL AT 300 MG/DL. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL. WHILE IN THE HOSPITAL, THE PATIENT AGAIN WENT THROUGH BLOOD TESTS, RECEIVED SHOTS AND UNSPECIFIED MEDICATION THROUGH INTRAVENOUS ROUTE, WHICH RESOLVED THE ISSUE. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. THE PATIENT STAYED IN THE HOSPITAL FOR THREE DAYS AND USED MULTIPLE DAILY INJECTIONS SINCE RELEASE 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 8681564 ↗
• InjuryMay 3, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED A KINKED CANNULA INFUSION SET. REPORTEDLY, HER BLOOD GLUCOSE WAS ABOVE 600 MG/DL AND SHE TRIED TO GIVE A BOLUS. SUBSEQUENTLY, SHE WENT TO THE EMERGENCY ROOM, AS HER BLOOD GLUCOSE HAD RISEN SUBSTANTIALLY AFTER SHE ATE A LARGE BREAKFAST. UPON ARRIVAL IN THE EMERGENCY ROOM, HER BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 500 MG/DL, HAD KETONES AND SHE STAYED THERE FOR SIX HOURS. THE HEALTH CARE PROFESSIONAL ASSESSED HER KETONE LEVEL AS DANGEROUS/LIFE THREATENING AND SHE RECEIVED UNSPECIFIED MEDICATION VIA INTRAVENOUS ROUTE. SHE WAS ADMITTED TO THE HOSPITAL, WITH BLOOD GLUCOSE LEVEL OF APPROXIMATELY 600 MG/DL, WHERE SHE RECEIVED INTRAVENOUS INSULIN DROPS AS CORRECTIVE TREATMENT, AND SHE HAD SOME BLOOD INVESTIGATIONS DONE WHICH RESOLVED THE ISSUE AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. SHE WAS RELEASED FROM THE HOSPITAL AFTER 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

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8576519 ↗
• InjuryApr 30, 2019Material Deformation; Material Deformation

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT HAD FACED A HOLE IN THE INFUSION SET TUBING AND HAD HIGH BLOOD GLUCOSE LEVELS, WHICH SHE SELF-TREATED WITH CORRECTION BOLUSES. REPORTEDLY, ON ARRIVAL IN THE EMERGENCY ROOM, THE BLOOD GLUCOSE LEVEL WAS 500 MG/DL AND THE HEALTH CARE PROFESSIONAL ASSESSED IT AS DANGEROUS/ LIFE THREATENING. THE PATIENT WAS IN THE EMERGENCY ROOM FOR FOUR TO FIVE HOURS AND SHE WAS GIVEN INTRAVENOUS INSULIN. THE PATIENT STILL EXPERIENCED HIGH BLOOD GLUCOSE, DIABETIC KETOACIDOSIS. SUBSEQUENTLY SHE WAS ADMITTED TO HOSPITAL. DURING HOSPITALIZATION, SHE RECEIVED INTRAVENOUS INSULIN AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. SHE WAS RELEASED FROM THE HOSPITAL AFTER SIX DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE INFUSION SET WAS USED FOR TWO DAYS. CURRENTLY, SHE WAS ON MULTIPLE DAILY INJECTION. THIS CASE HAS A SISTER COMPLAINT PRID: (B)(6), WHICH IS ALSO REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8563605 ↗
• InjuryApr 30, 2019Detachment 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 TUBING DISCONNECTED FROM THE SITE WHILE THE PATIENT WAS SLEEPING. HIGHEST BLOOD GLUCOSE LEVEL REPORTED WAS 607 MG/DL, WHICH THE PATIENT TRIED TO SELF-TREAT WITH A CORRECTION BOLUS USING THE PUMP. SUBSEQUENTLY, SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS WHERE SHE RECEIVED INTRAVENOUS INSULIN DRIP, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR TWO DAYS. SHE WAS HOSPITALIZED FOR TWO DAYS AND THEREAFTER, HER CONDITION WAS STABLE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8563520 ↗
• InjuryApr 30, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT HAD FACED BENT CANNULA ISSUE AND HAD HIGH BLOOD GLUCOSE LEVELS, WHICH SHE SELF-TREATED WITH CORRECTION BOLUSES. REPORTEDLY, ON ARRIVAL IN THE EMERGENCY ROOM, THE BLOOD GLUCOSE LEVEL WAS 500 MG/DL AND THE HEALTH CARE PROFESSIONAL ASSESSED IT AS DANGEROUS/ LIFE THREATENING. THE PATIENT WAS IN THE EMERGENCY ROOM FOR FOUR HOURS AND WAS GIVEN INTRAVENOUS INSULIN. THE PATIENT STILL EXPERIENCED HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. SUBSEQUENTLY SHE WAS ADMITTED TO THE HOSPITAL. DURING HOSPITALIZATION, SHE RECEIVED INTRAVENOUS INSULIN AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. SHE WAS ADMITTED FOR ONE AND A HALF WEEK AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE INFUSION SET WAS USED FOR TWO DAYS. CURRENTLY, SHE WAS ON MULTIPLE DAILY INJECTIONS. 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. THIS CASE HAS A SISTER COMPLAINT P

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8563407 ↗
• InjuryApr 29, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH A BENT CANNULA AND WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. HE WENT TO THE EMERGENCY AND STAYED THERE FOR A COUPLE OF HOURS. PATIENT'S BLOOD GLUCOSE WAS OVER 700 MG/DL WHEN ARRIVED AT THE EMERGENCY ROOM AND RECEIVED INSULIN THROUGH INTRAVENOUS ROUTE AS CORRECTIVE TREATMENT. HE HAD LARGE KETONES AND THE HEALTH CARE PROFESSIONAL ASSESSED THE KETONE LEVEL AS DANGEROUS/LIFE THREATENING. THE PATIENT WAS DIAGNOSED WITH ACUTE KIDNEY FAILURE, DIABETIC KETOACIDOSIS, HYPERGLYCEMIA, HYPERKALEMIA AND BLOOD GLUCOSE LEVEL WAS 300 MG/DL WHEN THE PATIENT LEFT THE EMERGENCY AND WAS SUBSEQUENTLY HOSPITALIZED. REPORTEDLY, THE PATIENT NOTICED THE CANNULA WAS BENT WHEN HE PULLED HIS SITE OUT WHILE IN THE HOSPITAL. HE WAS USING THE SAME INFUSION SET FOR 5 DAYS. THE PATIENT WAS TREATED WITH INSULIN DRIP, POTASSIUM AND MAGNESIUM. HE WAS HOSPITALIZED FOR MORE THAN 2 DAYS AND WAS STILL HOSPITALIZED AT THE TIME OF THE 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

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8559712 ↗
• 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 BENT CANNULA ISSUE AT INFUSION SITE. REPORTEDLY, THE PATIENT'S BLOOD GLUCOSE LEVEL AT THE TIME OF THE EVENT WAS 600 MG/DL AND HAD HIGH KETONES. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND RECEIVED INTRAVENOUS INSULIN AND SOME UNSPECIFIED DRIP TO TREAT DEHYDRATION, AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE HEALTH CARE PROFESSIONAL ASSESSED THE KETONE LEVEL AS DANGEROUS AND LIFE THREATENING. THE INFUSION SET WAS USED FOR LESS THAN THREE DAYS. SHE WAS HOSPITALIZED FOR THREE 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 UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8547986 ↗
• 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 BENT CANNULA. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 629 MG/DL AND EXPERIENCED DIABETIC KETOACIDOSIS. THE PATIENT WAS TAKEN TO THE EMERGENCY AND STAYED THERE FOR A FEW HOURS WHERE INTRAVENOUS INSULIN DRIP AND SOME UNSPECIFIED FLUIDS WERE GIVEN. THE HEALTH CARE PROFESSIONAL CONFIRMED THE ISSUE WAS DUE TO A KINKED CANNULA, WHICH WAS OBSERVED AFTER THE REMOVAL OF SITE FOR INSPECTION. THE PATIENT LOOKED PALE, LETHARGIC, AND MILDLY DEHYDRATED, WHEN LEFT THE EMERGENCY ROOM. SUBSEQUENTLY, THE PATIENT AND WAS ADMITTED IN THE INTENSIVE CARE UNIT AND RECEIVED INTRAVENOUS INSULIN DRIP AND SOME UNSPECIFIED FLUIDS AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE INFUSION SET WAS USED FOR APPROXIMATELY 12 HOURS. THE PATIENT WAS HOSPITALIZED FOR TWO 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 UPON REMOVAL CAN BEND SLIGH

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8547977 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED AN ISSUE WITH A BENT CANNULA PRIOR TO ITS INSERTION, IT CAME OUT OF THE BOX AND HE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE THE INFUSION SET HAD BEEN IN USE ON THE FIRST DAY AND HE SELF-TREATED HIMSELF WITH BOLUS. THE PATIENT HAD HIGH KETONES AND THE HEALTH CARE PROFESSIONAL IDENTIFIED THE KETONE LEVEL AS LIFE THREATENING. HE RECEIVED INTRAVENOUS INSULIN, DOPAMINE AND ELECTROLYTES AS A PART OF THE TREATMENT AND THIS RESOLVED THE ISSUE. HE WAS HOSPITALIZED FOR 4 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 8543433 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED KINKED CANNULA ISSUE DUE TO WHICH THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL, WHICH WAS SELF-TREATED WITH A BOLUS USING THE PUMP. THE PATIENT WENT TO THE EMERGENCY ROOM AND UPON ARRIVAL, BLOOD GLUCOSE LEVEL WAS 426 MG/DL. PATIENT'S LEVEL OF KETONES WAS IDENTIFIED AS DANGEROUS/LIFE THREATENING BY A HEALTH CARE PROFESSIONAL. IN THE EMERGENCY ROOM, TRIAGE WAS DONE, THE PUMP WAS REMOVED, PATIENT WAS PUT ON AN INSULIN DRIP AND THEY DREW THE PATIENT'S BLOOD. WHEN THE PATIENT LEFT THE EMERGENCY ROOM, BLOOD GLUCOSE LEVEL WAS 219 MG/DL AND THE PATIENT EXPERIENCED NAUSEA AND VOMITING. THE PATIENT STAYED IN THE EMERGENCY ROOM FOR APPROXIMATELY FIVE HOURS AND WAS THEN HOSPITALIZED. THE PATIENT RECEIVED INSULIN, FLUIDS AND PATIENT'S BASIC METABOLIC PANEL WAS MONITORED. THE INFUSION SET HAD BEEN IN USE FOR ONE DAY. THE PATIENT STAYED IN THE HOSPITAL FOR TWO DAYS. AT THE TIME OF THIS REPORT, ISSUE HAD RESOLVED, AND PATIENT WAS DOING WELL AT HOME. 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 INFUSIO

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8543388 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT OBSERVED A KINK IN THE CANNULA AND DID NOT THINK THAT THE CANNULA ENTERED THE PATIENT'S SKIN. DUE TO THIS, THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE APPROXIMATELY 600 MG/DL. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED WHERE THE PATIENT RECEIVED INSULIN AND INTRAVENOUS DRIP OF AN UNKNOWN MEDICATION, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR 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 8543367 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT CHANGED HIS INFUSION SET DUE TO A KINKED CANNULA AND ENCOUNTERED HIGH BLOOD GLUCOSE LEVEL. HE FACED THIS ISSUE WITH TWO INFUSION SETS. PATIENT'S BLOOD GLUCOSE LEVEL AT THE TIME OF THIS EVENT WAS 500 MG/DL. THE PATIENT CHANGED HIS INFUSION SET SITE, ADMINISTERED CORRECTION BOLUSES USING THE PUMP AND MULTIPLE DOSE INJECTIONS THERAPY BY INSULIN PENS, BUT IT DID NOT DECREASE. SUBSEQUENTLY, THE PATIENT WENT TO THE EMERGENCY ROOM AND CONTINUED PUMP THERAPY. THE CUSTOMER STATED THAT DUE TO HIS BLOOD GLUCOSE LEVEL BEING HIGH HE COULD NOT RECALL IF HE WAS ADMINISTERING THE CORRECT CORRECTION AMOUNTS VIA THE PUMP. THEN HE WAS TAKEN TO THE INTENSIVE CARE UNIT AND HOSPITALIZED. THE PATIENT RECEIVED INSULIN VIA INTRAVENOUS DRIP AS CORRECTIVE TREATMENT, WHICH MADE HIS BLOOD GLUCOSE LEVEL STABLE AND HE WAS RELEASED WITH THE USE OF THE PUMP. THE INFUSION SET HAD BEEN IN USE FOR ONE DAY. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTI

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8543359 ↗
• InjuryApr 22, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT CANNULA WAS BENT AT THE INFUSION SITE, PREVENTING DELIVERY OF INSULIN WHICH LAID TO HIGH BLOOD GLUCOSE LEVEL (498 MG/DL). THE PATIENT REQUESTED BOLUS ON THE PUMP. THE PATIENT WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVEL AND RECEIVED FLUIDS THROUGH INTRAVENOUS ROUTE AND ZOLFRAN WHICH RESOLVED THE ISSUE. THE INFUSION SET WAS IN USE FOR 2 DAYS. THE PATIENT WAS HOSPITALIZED FOR 14 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 8535281 ↗
• InjuryApr 22, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT CANNULA WAS COMPROMISED DUE TO WHICH PATIENT HAD HIGH BLOOD GLUCOSE LEVEL (600 MG/DL). THE PATIENT WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVEL AND RECEIVED LIQUID DIET AND DRIP THROUGH INTRAVENOUS ROUTE WHICH RESOLVED THE ISSUE. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. THE PATIENT 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 8535202 ↗
• InjuryApr 22, 2019Material Twisted/Bent; Material Twisted/Bent

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT HAD DIFFICULTY WITH HER INFUSION SETS AND HER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF EVENT. SOMETIMES SHE HAD KINKS OR BENDS IN HER CANNULAS INDICATING SHE WAS NOT RECEIVING INSULIN, LEADING TO HIGH BLOOD GLUCOSE LEVEL. THE PATIENT HAD ORANGE JUICE AND TOOK AN EXTRA SHOT OF INSULIN AS CORRECTIVE TREATMENT. THIS ISSUE OCCURRED WITH 2-3 INFUSION SETS. SHE WAS HOSPITALIZED DUE TO ELEVATED BLOOD GLUCOSE LEVEL. SHE RECEIVED FLUIDS AND EXTRA SHOTS OF INSULIN AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE INFUSION SET WAS IN USE FOR 1-2 DAYS. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. THE PATIENT WAS HOSPITALIZED FOR MORE THAN 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 8535112 ↗
• InjuryApr 22, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WENT INTO DIABETIC KETOACIDOSIS DUE TO A KINKED CANNULA. THE PATIENT WAS GIVEN MULTIPLE DAILY INJECTION. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED WHERE THE PATIENT RECEIVED MULTIPLE DAILY INJECTIONS, ANTI-NAUSEA MEDICINE AND UNKNOWN MEDICATION THROUGH INTRAVENOUS ROUTE, WHICH RESOLVED THE ISSUE. THE PATIENT STAYED IN THE HOSPITAL FOR SEVEN DAYS. FURTHERMORE, IT WAS REPORTED THAT SIMILAR INSTANCE TOOK PLACE IN THE PAST WHERE THE PATIENT MAY HAVE STAYED 2-3 DAYS IN THE HOSPITAL DUE TO HER KINKED CANNULA. THE SAME TREATMENT WAS RECEIVED AS IN THE ONE REPORTED. 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 8535045 ↗
• InjuryApr 22, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL RESULTING IN DIABETIC KETOACIDOSIS AS SHE WAS UNAWARE THAT THE PUMP HAD STOPPED ADMINISTERING INSULIN. SHE SELF-TREATED IT WITH AN INSULIN INJECTION. SUBSEQUENTLY, SHE WAS ADMITTED TO THE EMERGENCY ROOM AND UPON ARRIVAL, PATIENT'S BLOOD GLUCOSE LEVEL WAS MORE THAN 600 MG/DL AND LEVEL OF KETONES WAS IDENTIFIED AS DANGEROUS/LIFE THREATENING BY A HEALTHCARE PROFESSION. THE PATIENT WAS ADMINISTERED WITH INSULIN VIA SYRINGE AND METOPROLOL TO TREAT HEART RHYTHM IRREGULARITIES DIRECTLY RELATED TO DIABETIC KETOACIDOSIS, WHICH RESOLVED THE ISSUE. THE PATIENT STAYED IN THE EMERGENCY ROOM FOR EIGHT HOURS. WHEN SHE LEFT THE EMERGENCY ROOM, HER CONDITION WAS STABLE BUT WAS HOSPITALIZED FOR OBSERVATION. UPON REMOVAL OF HER CANNULA, SHE NOTICED THAT IT WAS BENT. THE INFUSION SET HAD BEEN IN USE FOR APPROXIMATELY 24 HOURS. 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 CA

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8535016 ↗