Enlite™ Sensor MMT-7008BRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169646407), received between Jun 27, 2017 and Aug 27, 2018 — classified as 5 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (9 reports).

2 other recalls cover devices cleared under the same FDA submission (P120010); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2018Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED INACCURATE READINGS AND TRIGGERED THRESHOLD SUSPEND. THE CUSTOMER'S BLOOD GLUCOSE WAS 189 MG/DL AND SENSOR GLUCOSE WAS 40 MG/DL AT THE TIME OF INCIDENT WHEN IT TRIGGERED THRESHOLD SUSPEND. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7816871 ↗
• InjuryJun 14, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE WAS HAVING BLEEDING AT THE SITE OF INSERTION FROM HER NEW SENSOR. SHE SAID THAT EVERY TIME SHE INSERTS A NEW SENSOR, SHE STARTS TO BLEED. HER BLOOD GLUCOSE WAS 446 MG/DL AND DECLINED TROUBLESHOOTING FOR THE HIGH BLOOD GLUCOSE. THE SENSOR WILL BE RETURNING FOR ANALYSIS. THE INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7603597 ↗
• MalfunctionDec 27, 2017Incorrect Or Inadequate Test Results; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE PATIENT¿S BLOOD GLUCOSE WAS 161 MG/DL AND THE SENSOR GLUCOSE WAS 60 MG/DL AT THE TIME OF THE INCIDENT. SENSOR GLUCOSE VALUE THAT TRIGGERED THE SUSPEND EVENT: 57 MG/DL. BLOOD GLUCOSE VALUE AT THE TIME OF SUSPEND WAS 201 MG/DL. CHANGE SENSOR AND CALIBRATION NOT ACCEPTED WERE ALSO REPORTED. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR IS EXPECTED TO BE RETURNED FOR ANALYSIS AND INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7148625 ↗
• MalfunctionNov 16, 2017Device Displays Incorrect Message; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 114 MG/DL AND THE SENSOR GLUCOSE WAS 79 MG/DL AT THE TIME OF THE INCIDENT. TROUBLESHOOT WAS PERFORMED. THE CUSTOMER STATED THAT INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE VALUES. THE SENSOR GLUCOSE VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 80 MG/DL AS WELL AS 79 MG/DL. THE THRESHOLD/LOW SUSPEND LIMIT IN SENSOR SETTINGS WAS 79 MG/DL. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7038616 ↗
• InjuryOct 10, 2017Incorrect, Inadequate or Imprecise Result or Readings; Device Displays Incorrect Message

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE OF 50MG/DL. CUSTOMER TREATED LOW BLOOD GLUCOSE WITH GLUCOSE TABLETS SO CUSTOMER¿S CURRENT BLOOD GLUCOSE AS 130MG/DL. CUSTOMER ALSO REPORTS SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 210MG/DL AND THE SENSOR GLUCOSE WAS 140MG/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 NOT RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 6939056 ↗
• InjurySep 18, 2017False Reading From Device Non-Compliance; Loss of Power; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 121 MG/DL AND THE SENSOR GLUCOSE WAS 46 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED HE HAD FALSE READINGS AND ALSO SHUTOFF IN THE MIDDLE OF THE NIGHT SUSPENDED . THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE PRODUCT WILL BE REPLACED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6874020 ↗
• MalfunctionSep 18, 2017Incorrect, Inadequate or Imprecise Result or Readings; Device Displays Incorrect Message

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER¿S SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 107 MG/DL AND THE SENSOR GLUCOSE WAS 60 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER UPGRADED INSULIN PUMPS, AND NOTED THEY WERE HAVING ISSUES WITH LOW BLOOD GLUCOSE LEVELS. CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. DURING TROUBLESHOOT, CUSTOMER STATED THEY DID NOT USE THE 2 TAPE METHOD BECAUSE IT WAS DIFFICULT FOR THEM TO GET THE TAPE OVER THE SENSOR. CUSTOMER WAS INSTRUCTED TO MONITOR SENSOR GLUCOSE PERFORMANCE. THE CUSTOMER WAS ADVISED REPLACEMENT SENSORS WILL BE SENT OUT. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6872180 ↗
• MalfunctionSep 11, 2017Incorrect, Inadequate or Imprecise Result or Readings; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 137 MG/DL AND THE SENSOR GLUCOSE WAS 60 MG/DL AT THE TIME OF THE INCIDENT. BLOOD GLUCOSE WAS 157 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. IT WAS EXPLAINED TO CUSTOMER THE PROPER INSERTION TECHNIQUES AND SITE LOCATION. THE SENSOR WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6855997 ↗
• MalfunctionSep 6, 2017Incorrect Or Inadequate Test Results; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 390 MG/DL AND THE SENSOR GLUCOSE WAS 90 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER REPORTS SENSORS ARE ONLY LASTING 2-3 DAYS, AROUND DAY 3 THEY START TO SHOW SENSOR GLUCOSE VALUE OF 100 MG/DL NO MATTER WHAT BLOOD GLUCOSE IS. IN MANY CASES CUSTOMER STATES THAT IT WILL PUT HIM IN THRESHOLD SUSPEND. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6847099 ↗
• MalfunctionAug 31, 2017Incorrect Or Inadequate Test Results

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 177 MG/DL AND THE SENSOR GLUCOSE WAS 75 MG/DL AT THE TIME OF THE INCIDENT. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE VALUES. THE CUSTOMER WAS ADVISED ISSUE IS MOST LIKELY DUE TO SENSOR NOT SITUATED PROPERLY. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. PRODUCTS WILL BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6834780 ↗
• MalfunctionAug 31, 2017Incorrect, 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 78 MG/DL AND THE SENSOR GLUCOSE WAS 45 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 CUSTOMER ALSO REPORTED A BLOOD GLUCOSE WAS 97 MG/DL AND THE SENSOR GLUCOSE WAS 56 MG/DL AT THE TIME OF THE INCIDENT. THRESHOLD/LOW SUSPEND LIMIT IN SENSOR SETTINGS WAS 65. THE CUSTOMER TREATED WITH FOOD AND DECLINED TROUBLESHOOT FOR THE LOW READINGS. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 6834625 ↗
• MalfunctionAug 23, 2017Invalid Sensing

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD SENSOR DISCREPANCIES. THE CUSTOMER¿S SENSOR GLUCOSE READING FROM THE REPORTED EVENT WAS 40 MG/DL WHILE THEIR BLOOD GLUCOSE READING WAS 89 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT INSULIN DELIVERY WAS SUSPENDED DUE TO A LOW SENSOR GLUCOSE OF 31 MG/DL. THE SUSPEND ON LOW LIMIT IN THE SENSOR SETTING WAS 60 MG/DL. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6815382 ↗
• InjuryAug 22, 2017Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL OF HIGH BLOOD GLUCOSE OF 435MG/DL AND SENSOR GLUCOSE AND BLOOD GLUCOSE DIFFERENCES. THE CUSTOMER TREATED WITH THE INSULIN PUMP. CUSTOMER DECLINED TO TROUBLESHOOT FOR THE HIGH BLOOD GLUCOSE. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6812341 ↗
• MalfunctionAug 21, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 95 MG/DL AND THE SENSOR GLUCOSE WAS 40 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 NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6808123 ↗
• MalfunctionAug 11, 2017Low Readings

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 142 MG/DL AND THE SENSOR GLUCOSE WAS 101 MG/DL AT THE TIME OF THE INCIDENT. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE VALUES. THE CUSTOMER WAS ADVISED ISSUE IS MOST LIKELY DUE TO SENSOR NOT SITUATED PROPERLY. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. SENSOR GLUCOSE VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 70. THE SENSOR WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6790360 ↗
• InjuryJul 18, 2017Low Readings

  THE CUSTOMER'S FATHER REPORTED VIA PHONE CALL THAT HIS DAUGHTER EXPERIENCED SENSOR GLUCOSE VERSUS BLOOD GLUCOSE DIFFERENCES WITH THRESHOLD SUSPEND. CUSTOMER'S SENSOR GLUCOSE WAS 40 AND BLOOD GLUCOSE WAS 450 MG/DL. CUSTOMER WAS ADVISED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE WERE NOT WITHIN ACCEPTABLE RANGE. THE CALLER DECLINED TROUBLESHOOTING FOR ANY OTHER ISSUES. THE INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS. THE SENSOR WILL BE RETURNING FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6721659 ↗
• MalfunctionJun 27, 2017Device Displays Incorrect Message; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARMS. THE CUSTOMER¿S BLOOD GLUCOSE VALUES WERE 234 MG/DL, 176 MG/DL, AND 172 MG/DL AND THE SENSOR GLUCOSE VALUES WERE 68 MG/DL, 44 MG/DL, AND 40 MG/DL AT THE TIME OF THE INCIDENTS. THE CUSTOMER STATED THAT THE SUSPENDED ON LOW LIMIT IN SENSOR SETTINGS WAS 70. 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 6672252 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P120010. One submission often covers many models, so check the product and lot details in each record.

• Z-1751-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 530G Insulin Pump (MMT-551, MMT-751)
• Z-2544-2014 · Mar 13, 2014 · Terminated
  Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K