EnliteRecalls & reported problems across all models

We found 2 models of Enlite by Medtronic Minimed, Inc. in the FDA's device registry (GUDID). Together they are named in 1,030 adverse event reports in the FDA's MAUDE database, received between Jan 8, 2018 and Nov 3, 2023 — classified as 215 injuries, 815 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (640 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Enlite problems

Enlite models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Enlite ® MMT-7008A

  Automated insulin dosing , threshold suspend
  994 reports
• Enlite ® MMT-7008B

  Automated insulin dosing , threshold suspend
  36 reports

Recent Enlite adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2023Unexpected Therapeutic Results; Use of Device Problem; Calibration Problem; Unexpected Therapeutic Results; Use of Device Problem; Calibration Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 500 MG/DL AND 45 MG/DL AT THE TIME OF THE EVENT BUT THE CUSTOMER WAS NOT FEELING HIGH/LOW BLOOD GLUCOSE. THE CUSTOMER ALSO REPORTED A SENSOR GLUCOSE VS BLOOD GLUCOSE READING MISMATCH. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE BLOOD GLUCOSE VALUE WAS 326 MG/DL AND THE SENSOR GLUCOSE VALUE WAS 52 MG/DL AT THE TIME OF THE EVENT. THE INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE SENSOR AND WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 18062773 ↗
• MalfunctionJul 23, 2020Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Communication or Transmission Problem; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Communication or Transmission Problem

  INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A THRESHOLD SUSPEND. THE CUSTOMER¿S BLOOD GLUCOSE WAS 150 MG/DL AND SENSOR GLUCOSE WAS UNKNOWN AT THE TIME OF THE EVENT, THE DIFFERENCE IS OUTSIDE THE ACCEPTABLE RANGE. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS AT 70 MG/DL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10312802 ↗
• MalfunctionJul 22, 2020Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results

  INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A THRESHOLD SUSPEND. THE CUSTOMER¿S BLOOD GLUCOSE WAS 70 MG/DL AND SENSOR GLUCOSE WAS 40 MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE IS OUTSIDE THE ACCEPTABLE RANGE. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS AT 70 MG/DL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10308061 ↗
• MalfunctionJul 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results

  INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A THRESHOLD SUSPEND. THE CUSTOMER¿S BLOOD GLUCOSE WAS 90 MG/DL AND SENSOR GLUCOSE WAS 58 MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE IS OUTSIDE THE ACCEPTABLE RANGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10256175 ↗
• MalfunctionJul 8, 2020Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER STATED CANNULA WAS NOT THERE AT ALL, UNSURE IF IT WAS BAD OUT OF BOX OR WAS STUCK INSIDE HIM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER ALSO CONFIRMED IT WAS NOT CRIMPED, CANNULA WAS JUST COMPLETELY GONE. CUSTOMER LOOKED IN NEEDLE HOUSING AND INSIDE SENSOR AREA AND SEES NOTHING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10243953 ↗
• MalfunctionJul 2, 2020Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SENSOR ELECTRODE WAS BROKE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10223148 ↗
• MalfunctionJun 29, 2020Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Calibration Problem

  INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A THRESHOLD SUSPEND. THE CUSTOMER¿S BLOOD GLUCOSE WAS 180 MG/DL AND SENSOR GLUCOSE WAS 70 MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE IS OUTSIDE THE ACCEPTABLE RANGE. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS AT 70 MG/DL. THEY ALSO RECEIVED CALIBRATION NOT ACCEPTED ALARM AND CHANGE SENSOR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10205457 ↗
• MalfunctionJun 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A THRESHOLD SUSPEND. THE CUSTOMER¿S BLOOD GLUCOSE WAS 205 MG/DL AND SENSOR GLUCOSE WAS 50 MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE IS OUTSIDE THE ACCEPTABLE RANGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10166474 ↗
• MalfunctionJun 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A THRESHOLD SUSPEND. THE CUSTOMER¿S BLOOD GLUCOSE WAS 205 MG/DL AND SENSOR GLUCOSE WAS 50 MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE IS OUTSIDE THE ACCEPTABLE RANGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10166447 ↗
• MalfunctionJun 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results

  INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A THRESHOLD SUSPEND. THE CUSTOMER¿S BLOOD GLUCOSE WAS 170 MG/DL AND SENSOR GLUCOSE WAS 60 MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE IS OUTSIDE THE ACCEPTABLE RANGE. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS AT 70 MG/DL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10136943 ↗
• InjuryMay 29, 2020Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event; Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 49 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO STATED THAT SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 161 MG/DL AND THE SENSOR GLUCOSE WAS 54 MG/DL AT THE TIME OF THE INCIDENT. LOW LIMIT SETTING WAS 80 MG/DL. THE CUSTOMER¿S OTHER BLOOD GLUCOSE WAS 179 MG/DL, 173 MG/DL AND THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR LOW BLOOD GLUCOSE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10100380 ↗
• MalfunctionMay 27, 2020Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Calibration Problem

  INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A THRESHOLD SUSPEND. THE CUSTOMER¿S BLOOD GLUCOSE WAS 194 MG/DL AND SENSOR GLUCOSE WAS 55 MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE IS OUTSIDE THE ACCEPTABLE RANGE. CUSTOMER STATED DIFFERENCE WERE 100 POINTS OFF. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10092239 ↗
• MalfunctionMay 26, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED VIA PHONE THAT THEY EXPERIENCING LOW BLOOD GLUCOSE LEVEL FOR 51 MG/DL. SENSOR WAS NOTIFYING GLUCOSE LEVEL 70MG/DL, IT WAS MORE THAN ACTUAL BLOOD GLUCOSE. CUSTOMER TREATED LOW BLOOD GLUCOSE LEVEL WITH CARBOHYDRATE INTAKE. CUSTOMER DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE LEVEL. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10090351 ↗
• MalfunctionMay 4, 2020Calibration Problem; Calibration Problem

  INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A THRESHOLD SUSPEND. THE CUSTOMER¿S BLOOD GLUCOSE WAS 148MG/DL AND SENSOR GLUCOSE WAS 60MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE IS OUTSIDE THE ACCEPTABLE RANGE. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS AT 60 MG/DL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10021169 ↗
• MalfunctionMay 4, 2020Calibration Problem; Calibration Problem

  INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A THRESHOLD SUSPEND. THE CUSTOMER¿S BLOOD GLUCOSE WAS 148MG/DL AND SENSOR GLUCOSE WAS 60MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE IS OUTSIDE THE ACCEPTABLE RANGE. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS AT 60 MG/DL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10021164 ↗

Other Medtronic Minimed, Inc. products

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• MiniMed670G2 models · 28,871 reports · 3 recalls
• MiniMed630G2 models · 6,656 reports · 5 recalls
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