Mio® MMT-923600Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05705244007710), received between Jan 22, 2019 and Dec 7, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2021Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT WAS VERY ILL, HARD TO BREATH, UNSTEADY ON THE FEET, FEELING DIZZY AND EXPERIENCED HIGH BLOOD GLUCOSE LEVEL (24.0 MMOL/L). THEREFORE, THE PATIENT GOT INSULIN FLOW BLOCKED ALARM AT 03:03 AM, 07:04 AM AND 07:05 AM, RESPECTIVELY. THEY TRIED TO TREAT THE HIGH BLOOD GLUCOSE LEVEL BY CHANGING THE INFUSION SET (LAST CHANGED ON (B)(6) 2021) AND GAVE A BOLUS. THE PATIENT'S SITE LOCATION WAS RIGHT SIDE OF THE ABDOMEN. SUBSEQUENTLY, ON THE DAY OF THIS REPORT ((B)(6) 2021), AT 07:15 AM, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE LEVEL OF 24.0 MMOL/L AND WAS TESTED FOR KETONE LEVEL (2.2 MMOL/L). DURING HOSPITALIZATION, THE PATIENT RECEIVED INSULIN INTRAVENOUSLY AS CORRECTIVE TREATMENT. AFTER SPENDING THREE HOURS, THE PATIENT WAS STILL IN THE HOSPITAL AT THE TIME OF THIS REPORT AND CURRENT BLOOD GLUCOSE LEVEL WAS REPORTED TO BE 10.6 MMOL/L. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 12947809 ↗
• MalfunctionNov 13, 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 HAD DETACHED FROM THE CLIP. REPORTEDLY, THE PATIENT WOKE UP WITH HIGH BLOOD GLUCOSE LEVEL AND FELT SICK. FURTHER, THE SET HAD BROKEN TWICE THIS WEEK, 2 TIMES IN A ROW, AS PER REPORT DATED 03-SEP-2019. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9313731 ↗
• MalfunctionMay 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT INFUSION SET'S TUBING DETACHED AT THE SITE WHILE THE PATIENT WAS SLEEPING. THE SITE LOCATION WAS PATIENT'S LEG AND THE PUMP WAS ON THE BELT. THE INFUSION HAD BEEN IN USE FOR TWO DAYS AND THE INFUSIONS WERE NOT STORED AT EXTREME TEMPERATURES. THE PATIENT WAS UNSURE OF ANY STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. UPON INVESTIGATION OF THE RETURNED USED DEVICE, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8635066 ↗
• MalfunctionJan 28, 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 HER INFUSION SET FELL APART AT NIGHT WHEN SHE WAS SLEEPING. REPORTEDLY, THE TUBING GOT SEPARATED FROM THE CLIP AT THE QUICK-RELEASE AND THE CLIP ITSELF WAS CONNECTED TO THE SITE. SHE WOKE UP WITH BLOOD GLUCOSE LEVEL OF 18 MMOL/L. SHE CHANGED THE INFUSION SITE AND HER BLOOD GLUCOSE LEVEL DROPPED DOWN TO 9.3 MMOL/L AT THE TIME OF THIS REPORT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8280536 ↗
• InjuryJan 22, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT WAS HOSPITALIZED WITH HIGH BLOOD GLUCOSE. REPORTEDLY SHE WAS VOMITING CONSTANTLY. THE PATIENT'S BLOOD GLUCOSE WAS 30 PLUS 3 WHICH WENT UPTO 30 PLUS 10 WHEN DIAGNOSED BY HEALTH CARE PROFESSIONAL AT TIME OF HOSPITALIZATION. THE PATIENT WAS GIVEN INTRAVENOUS FLUIDS, PUMP WAS REMOVED, AND MONITORING WAS DONE FOR A WEEK AND BLOOD TEST WERE TAKEN AS A CORRECTIVE TREATMENT. THE PATIENT REPORTED, WHEN SHE REMOVED THE INFUSION SET, THE CANNULA WAS BENT. THE PATIENT REPORTED SHE GAVE HERSELF BOLUS TO TREAT HIGH BLOOD GLUCOSE AND FELT ILL BEFORE HOSPITALIZATION. 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 8266114 ↗