Mio® MMT-975600Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05705244007857), received between Dec 12, 2018 and Oct 30, 2020 — classified as 1 injury, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2020Detachment 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 GOT DETACHED WHERE THE CANNULA IS CONNECTED WHILE HE WAS SITTING DOWN AT HIS LAPTOP DOING WORK. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE PUMP WAS CLIPPED ON TO HIS BELT. MOREOVER, THE INFUSION 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 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 10760577 ↗
• MalfunctionAug 18, 2020Detachment 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 SEPARATED FROM THE CANNULA WHILE PRIMING THE TUBING. FURTHER, THE PATIENT HAD JUST PRIMED IT AND WAS GETTING READY TO INSERT AN INFUSION SET. THE INFUSION HAD BEEN USED FOR THE SAME DAY. THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. MOREOVER, THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THEIR BODY. UPON INVESTIGATION OF THE RETURNED USED DEVICE (ONE USED CONNECTOR), IT WAS FOUND THAT THE TUBING CONNECTOR DETACHED (MISSING GLUE) ALSO A DROP OF GLUE ON THE TOP OF THE INFUSION SET CONNECTOR WAS FOUND. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10418858 ↗
• MalfunctionMar 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT WAS A LIFE GUARD AND HE REPORTED THAT FEW DAYS BEFORE THIS REPORT, HIS BLOOD SUGAR LEVEL CLIMBED UP TO OVER 20 MMOL/L WHEN HE NOTICED THAT HIS SET HAD BROKEN. HE THOUGHT NOTHING OF IT BECAUSE HE ALWAYS KEPT HIS PUMP ON HIS BELT AND THOUGHT THAT HE HAD ZIPPERED THE LINE AND BROKE IT BY ACCIDENT. ON THE DAY OF THIS REPORT, AFTER HE HAD PRIMED THE LINE AND WHILE HE WAS CHANGING HIS SITE, HE HAD UNCOILED IT TO BE ABLE TO INSERT BUT IT BROKE IN HIS HANDS. BOTH OF HIS INFUSION SETS WERE FROM THE SAME CONTAINER THAT BROKE FROM THE SAME SPOT. IT HAD APPEARED AS IF THE SITES WERE GETTING KINKED FROM WHERE THE LINE IS LOCKED IN ON THE INSERTION DEVICE. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE PUMP WAS WORN ON HIS WAIST. THE LOCATION OF DETACHMENT WAS AT THE TUBING. THE INFUSION HAD BEEN IN USE SINCE LAST THREE DAYS AND THE INFUSIONS WERE STORED IN A CUPBOARD IN THE KITCHEN. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO HIS BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8442851 ↗
• InjuryDec 12, 2018Material Twisted/Bent; Material Twisted/Bent

  (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT WAS HOSPITALIZED AS HIS BLOOD GLUCOSE LEVEL WERE HIGH AND SHE EXPERIENCED DIABETIC KETOACIDOSIS. REPORTEDLY THE HIGH BLOOD GLUCOSE WAS DUE TO KINKED CANNULA. THE PATIENT'S BLOOD GLUCOSE LEVEL AT TIME OF INCIDENT WAS 60MMOL\L. THE PATIENT SIGNS AND SYMPTOMS OF NAUSEA AND WAS NOT FEELING WELL. SHE RECEIVED INSULIN THERAPY AS CORRECTIVE TREATMENT. SHE WAS NONCONSCIOUS DURING THE THREE DAYS OF HOSPITALIZATION. CURRENTLY HER BLOOD GLUCOSE LEVEL WAS 4.1 MMOL\L. 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 8154367 ↗