Enlite SensorRecalls & reported problems across all models

We found 2 models of Enlite Sensor by Medtronic Minimed, Inc. in the FDA's device registry (GUDID). Together they are named in 1,329 adverse event reports in the FDA's MAUDE database, received between May 22, 2017 and Nov 11, 2019 — classified as 241 injuries, 1,088 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (556 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 Sensor problems

Enlite Sensor models

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

• Enlite® Sensor MMT-7008A

  Artificial pancreas device system, threshold suspend
  1,312 reports
• Enlite™ Sensor MMT-7008B

  Artificial pancreas device system, threshold suspend
  17 reports

Recent Enlite Sensor adverse event reports

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

• MalfunctionNov 11, 2019Incorrect, Inadequate or Imprecise Result or Readings; Failure to Deliver

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. CUSTOMER REPORTED THAT THIS MORNING IT SAY BLOOD GLUCOSE WAS 57 MG/DL AND IT MUST HAD SHUT OFF SINCE IT SHUTS OFF AT 60 MG/DL. THE CUSTOMER¿S BLOOD GLUCOSE WAS 268 MG/DL AND THE SENSOR GLUCOSE WAS 58 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED THAT INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE VALUES. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9303524 ↗
• MalfunctionAug 13, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 110 MG/DL AND THE SENSOR GLUCOSE WAS 68 MG/DL AT THE TIME OF THE INCIDENT. THE LOWER LIMIT IN SENSOR SETTING WAS 70 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE VALUES. THE CUSTOMER'S OTHER BLOOD GLUCOSE LEVEL WAS 155 MG/DL. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8887272 ↗
• InjuryApr 22, 2019Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM AND THE CUSTOMER EXPERIENCED THE HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 120, 300, 400 MG/DL AND SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 80 MG/DL. THE INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE CUSTOMER STATED THAT THERE WAS LOSS OF COMMUNICATION. THE CUSTOMER DECLINED THE HIGH BLOOD GLUCOSE TROUBLESHOOTING. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8535123 ↗
• MalfunctionFeb 20, 2019Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results

  THE CUSTOMER'S MOTHER WAS REPORTED VIA PHONE CALL THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 130 MG/DL, 80 MG/DL AND THE SENSOR GLUCOSE WAS 60 AT THE TIME OF THE INCIDENT. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE VALUES. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8353063 ↗
• MalfunctionFeb 7, 2019Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 91 MG/DL AND THE SENSOR GLUCOSE WAS 62 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 79 MG/DL. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 90 MG/DL. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8314508 ↗
• MalfunctionJan 11, 2019Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 320 MG/DL AND THE SENSOR GLUCOSE WAS 40 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 40. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS BELOW 40 MG/DL. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8239159 ↗
• MalfunctionNov 13, 2018Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 69 MG/DL AND THE SENSOR GLUCOSE WAS 168 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 69. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS UNKNOWN. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8067867 ↗
• MalfunctionOct 15, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 110 MG/DL AND THE SENSOR GLUCOSE WAS 50 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7964192 ↗
• MalfunctionOct 4, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE PATIENT¿S BLOOD GLUCOSE WAS 187 MG/DL AND THE SENSOR GLUCOSE WAS 40 MG/DL AT THE TIME OF THE INCIDENT. DIFFERENCE BETWEEN BLOOD GLUCOSE AND SENSOR GLUCOSE WAS 147 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE VALUES. SENSOR GLUCOSE VALUE THAT TRIGGERED THE SUSPEND EVENT WAS UNKNOWN. THRESHOLD/LOW SUSPEND LIMIT IN SENSOR SETTINGS WAS 60 MG/DL. CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7933126 ↗
• MalfunctionSep 27, 2018Calibration Problem; Calibration Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR HAD CHANGE SENSOR ALERT. THE CUSTOMER¿S BLOOD GLUCOSE WAS 115 MG/DL. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7916914 ↗
• MalfunctionSep 27, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR HAD NEEDLE PULLING OUT THE CANNULA WHEN REMOVED IT, THE CUSTOMER¿S BLOOD GLUCOSE WAS 111 MG/DL. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7916912 ↗
• InjurySep 21, 2018Fracture; Fracture

  CALLER REPORTED VIA PHONE CALL ON (B)(6) 2018 THAT THE NEEDLE OF THE SENSOR HAD BEEN FRACTURED INSIDE THE CUSTOMER'S ARM. BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: Pain

  MAUDE report 7900039 ↗
• MalfunctionSep 19, 2018Unexpected Therapeutic Results; Unexpected Therapeutic Results

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE 93 MG/DL AND SENSOR GLUCOSE LEVELS WERE 66 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED HAVING ISSUES WITH THE SENSOR. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WILL NOT RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7891719 ↗
• MalfunctionSep 13, 2018Calibration Problem; Calibration Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 154 MG/DL AND THE SENSOR GLUCOSE WAS 52 MG/DL AT THE TIME OF THE INCIDENT. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE VALUES. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7873845 ↗
• MalfunctionSep 11, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 218 MG/DL AND THE SENSOR GLUCOSE WAS 169 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 80 MG/DL. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 80 MG/DL. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7863227 ↗

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