Enlite® Sensor MMT-7008ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1,312 adverse event reports that list this exact device (DI 20643169646432), received between May 22, 2017 and Nov 11, 2019 — classified as 236 injuries, 1,076 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (552 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 25 most recent of 1,312 reports, 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 ↗
• InjurySep 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 68MG/DL, 202, MG/DL AND SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 68 MG/DL. THE INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. THE LOW BLOOD GLUCOSE WAS TREATED BY EATING DINNER. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WILL BE AND INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7863214 ↗
• InjurySep 6, 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 RANGING FROM 215 TO 225 MG/DL AND THE SENSOR GLUCOSE WAS RANGING FROM 60 TO 80 MG/DL AT THE TIME OF THE INCIDENT. BLOOD GLUCOSE AT THE TIME OF THE CALL WAS 198 MG/DL AND SENSOR GLUCOSE WAS 398 MG/DL. THE CUSTOMER ALSO REPORTED THAT THE BLOOD GLUCOSE REACHED 364 MG/DL. THE CUSTOMER WAS ADVISED TO REPLACE SENSOR AS IT WAS NOT TRACKING PROPERLY. THE SENSOR WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7851980 ↗
• MalfunctionSep 6, 2018Unexpected Therapeutic Results; Unexpected Therapeutic Results

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMERS BLOOD GLUCOSE LEVELS WERE 150 MG/DL AND SENSOR GLUCOSE LEVELS WERE 58 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 7849897 ↗
• InjurySep 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 CUSTOMER¿S BLOOD GLUCOSE WAS 210 MG/DL AND THE SENSOR GLUCOSE WAS IN THE 59 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THEY HAVE BEEN EATING THINKING THAT THEY WERE LOW. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE SENSOR WAS REPLACED BUT CUSTOMER WILL NOT RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7844478 ↗
• InjurySep 4, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED VIA PHONE CALL THAT HER BLOOD GLUCOSE LEVELS HAVE BEEN GOING UP AND DOWN AND SHE WAS HAVING SENSOR WITH INACCURATE READINGS. THE CUSTOMER'S BLOOD GLUCOSE REACHED 500 MG/DL ON (B)(6) 2017. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE CALL WAS 240 MG/DL. THE CUSTOMER STATED THAT SHE MOVES AROUND A LOT DURING HER SLEEP AND HER INFUSION SETS RIP OFF HER INSERTION SITE. THE CUSTOMER STATED THAT SHE TREATED HER HIGH BLOOD GLUCOSE WITH INSULIN PUMP BUT SHE WENT LOW, SO SHE TREATED WITH MANUAL INJECTIONS INSTEAD. THE CUSTOMER ALSO REPORTED DISCREPANCIES IN SENSOR READINGS THAT TRIGGERED THRESHOLD SUSPEND. BLOOD GLUCOSE WAS 239 MG/DL AND SENSOR GLUCOSE WAS 40 MG/DL OR BELOW. CUSTOMER DID NOT TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. NO PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7843652 ↗
• MalfunctionSep 4, 2018Incorrect, 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 252 MG/DL AND THE SENSOR GLUCOSE WAS 110 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: Hyperglycemia

  MAUDE report 7841207 ↗
• MalfunctionSep 4, 2018Incorrect, 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 137 MG/DL AND THE SENSOR GLUCOSE WAS 80 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: Hypoglycemia

  MAUDE report 7841206 ↗
• MalfunctionSep 4, 2018Incorrect, 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 200 MG/DL AND THE SENSOR GLUCOSE WAS 140 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: Hypoglycemia; Pain

  MAUDE report 7841200 ↗
• MalfunctionAug 31, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED INACCURATE READING AND TRIGGERED THRESHOLD SUSPEND. THE CUSTOMER'S BLOOD GLUCOSE WAS AROUND 300 MG/DL AND SENSOR GLUCOSE WAS 58 MG/DL AT THE TIME WHEN THRESHOLD SUSPEND WAS TRIGGERED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7840357 ↗
• MalfunctionAug 30, 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 158, 159, 175 MG/DL AND THE SENSOR GLUCOSE WAS 40, 45 MG/DL AT THE TIME OF THE INCIDENT. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER REPORTED THAT THERE WAS CALIBRATION NOT ACCEPTED AND CHANGE SENSOR ALARM. 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 7832681 ↗

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