Guardian™ Sensor (3) MMT-7020BRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00763000140779), received between Aug 16, 2018 and Jul 10, 2020 — classified as 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (27 reports).

14 other recalls cover devices cleared under the same FDA submission (P160017); 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. 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• 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 150 MG/DL AND SENSOR GLUCOSE WAS 80 MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE WAS OUTSIDE THE ACCEPTABLE RANGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Blood Loss

  MAUDE report 10256471 ↗
• MalfunctionApr 24, 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 196MG/DL AND SENSOR GLUCOSE WAS 85MG/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 9994787 ↗
• MalfunctionApr 16, 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 313 MG/DL AND SENSOR GLUCOSE WAS 47 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 CUSTOMER ALSO REPORTED GETTING CALIBRATION AND CHANGE SENSOR ERRORS. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9970185 ↗
• MalfunctionApr 11, 2020Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem

  INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A THRESHOLD SUSPEND. THE CUSTOMER¿S BLOOD GLUCOSE WAS 280 MG/DL AND SENSOR GLUCOSE WAS 42 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 9951353 ↗
• MalfunctionMar 17, 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 170 MG/DL AND SENSOR GLUCOSE WAS 40 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 9841033 ↗
• MalfunctionMar 5, 2020Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 107 MG/DL AND THE SENSOR GLUCOSE WAS 48 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE VALUES. LOW LIMIT IN SENSOR SETTING WAS 60 MG/DL. 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 9791673 ↗
• MalfunctionFeb 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem

  INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A THRESHOLD SUSPEND. THE CUSTOMER¿S BLOOD GLUCOSE WAS 81 MG/DL OR 84 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 80 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 9738307 ↗
• MalfunctionDec 2, 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 SUSPENDED BLOOD GLUCOSE WAS 119 MG/DL AND THE SENSOR GLUCOSE WAS 80 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE AND BLOOD GLUCOSE. 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: Blood Loss

  MAUDE report 9393513 ↗
• MalfunctionNov 15, 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 184 MG/DL AND THE SENSOR GLUCOSE WAS 65 MG/DL. CUSTOMER REPORTED OTHER BLOOD GLUCOSE VALUE WAS 150 MG/DL. 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 SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9325961 ↗
• InjuryOct 12, 2019Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem

  IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS 180 MG/DL.

  Patient problems: Hypoglycemia

  MAUDE report 9183411 ↗
• MalfunctionSep 20, 2019Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; 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 106 MG/DL AND SENSOR GLUCOSE VALUE WAS 45 MG/DL. INSULIN DELIVERY WAS NOT SUSPENDED DUE TO SENSOR GLUCOSE AND BLOOD GLUCOSE. SENSOR GLUCOSE VALUE THAT TRIGGERED SUSPEND EVENT WAS 45 MG/DL. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 80 MG/DL. BLOOD GLUCOSE VALUE ASSOCIATED WITH THE TRIGGERED SUSPEND EVENT WAS 160 MG/DL. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. CUSTOMER DID NOT RECEIVE A SENSOR UPDATING ALERT. CUSTOMER DID RECEIVE A CALIBRATION NOT ACCEPTED ALERT. CUSTOMER DID RECEIVE A CHANGE SENSOR ALERT. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9096484 ↗
• MalfunctionSep 13, 2019Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. THE CUSTOMER¿S BLOOD GLUCOSE WAS 157 MG/DL AND THE SENSOR GLUCOSE WAS 46 MG/DL AT THE TIME OF THE INCIDENT. THE INSULIN PUMP RECEIVED SENSOR UPDATING AND CHANGE SENSOR. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9050674 ↗
• MalfunctionSep 5, 2019Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 377 MG/DL. SENSOR GLUCOSE LEVEL AT THE EVENT WAS 118 MG/DL. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE 259 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE DIFFERENCE IN BLOOD AND SENSOR GLUCOSE VALUE. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8964747 ↗
• MalfunctionAug 23, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THE INTRODUCER NEEDLE WAS FRACTURED WHILE IN THE BODY. THE CUSTOMER'S BLOOD GLUCOSE WAS 190 MG/DL. THE SENSOR THAT GOT STUCK BECAUSE OF THE BENT NEEDLE. THE CUSTOMER STATED THAT THE NEEDLE WAS NOT ABLE TO RETRACT. CUSTOMER WAS HAVING A HARD TIME REMOVING THE NEEDLE ASSEMBLY. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8924274 ↗
• MalfunctionJul 23, 2019Break; Break

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR ELECTRODE WAS LEFT UNDER HIS SKIN. BLOOD GLUCOSE LEVEL OF THE CUSTOMER WAS UNKNOWN. THE CUSTOMER STATED THAT THE WHEN HE WAS ABOUT TO CHANGE SENSOR THE SENOR FRACTURED WHILE IN THE BODY. THE CUSTOMER ALSO STATED THAT HE DID NOT RECEIVED ANY MEDICAL TREATMENT AS A RESULT OF THE SENSOR FRACTURE AND IT IS STILL IN THE BODY. SENSOR WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 8815090 ↗
• MalfunctionJul 18, 2019Break; Break

  THE CUSTOMER REPORTED VIA PHONE CALL THAT SENSOR FRACTURED WHILE IN THE BODY. BLOOD GLUCOSE WAS 212 MG/DL. CUSTOMER INSERTED A SENSOR AND WHEN HE TRIED TO ATTACH HIS SENSOR THE SENSOR SNAPPED OFF AND THE CANNULA WAS STILL IN HIS SKIN. CUSTOMER ALSO REPORTED THAT THEY DID NOT RECEIVE MEDICAL TREATMENT AS A RESULT OF THE SENSOR FRACTURING WHILE STILL IN THE BODY AND NEEDLE WAS NOT HARD TO REMOVE FROM BODY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8801661 ↗
• MalfunctionJul 10, 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 153 MG/DL AND SENSOR GLUCOSE WAS 81 MG/DL. CUSTOMER¿S OTHER BLOOD GLUCOSE LEVEL WAS 132 MG/DL, 104 MG/DL AND 83 MG/DL. 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 8777841 ↗
• MalfunctionJun 28, 2019Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Calibration Problem

  "THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM." THE CUSTOMER¿S BLOOD GLUCOSE WAS 115 MG/DL AND THE SENSOR GLUCOSE WAS 44 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: Blood Loss; Hypoglycemia

  MAUDE report 8743627 ↗
• MalfunctionJun 17, 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 76 MG/DL, 156 MG/DL AND SENSOR GLUCOSE VALUE WAS 60 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE AND BLOOD GLUCOSE. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 60 MG/DL. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 60 MG/DL. BLOOD GLUCOSE VALUE ASSOCIATED WITH THE TRIGGERED SUSPEND EVENT WAS 215 MG/DL. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE CUSTOMER DECLINED TROUBLESHOOTING. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703012 ↗
• MalfunctionJun 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 172 MG/DL AND THE SENSOR GLUCOSE WAS 70 MG/DL. 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 SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674158 ↗
• MalfunctionMay 24, 2019Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; 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 297 MG/DL AT THE TIME OF THE INCIDENT. THE INSULIN DELIVERY WAS SUSPENDED DUE TO THE SENSOR VALUES. THE CUSTOMER STATED THAT THE SENSOR VALUE THAT TRIGGERED THE SUSPEND ON LOW OR SUSPEND BEFORE LOW EVENT WAS 85 MG/DL. THE SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 90 MG/DL. THE BLOOD GLUCOSE VALUE ASSOCIATED WITH THE TRIGGERED SUSPEND EVENT WAS 295 MG/DL. THE CUSTOMER REPORTED THAT THE DIFFERENCE OCCURS WITH THE PREVIOUS SENSOR. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8639460 ↗
• MalfunctionMay 15, 2019Break; Break

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE NEEDLE WAS BROKEN OF THE SENSOR. THE CUSTOMER¿S BLOOD GLUCOSE VALUE WAS 120 MG/DL. CUSTOMER ASSISTED WITH TROUBLESHOOTING. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8611000 ↗
• MalfunctionMay 8, 2019Fracture; Fracture

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED PROBLEM REMOVING THE INTRODUCER NEEDLE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 104 MG/DL. CUSTOMER NOT REPORTING THAT THE SENSOR OR INTRODUCER NEEDLE FRACTURED WHILE IN THE BODY. CUSTOMER REPORTS THE INTRODUCER NEEDLE WAS NO LONGER IN THE BODY. CUSTOMER REPORTS THAT THEY DID NOT RECEIVE MEDICAL TREATMENT AS A RESULT OF THE NEEDLE FRACTURING WHILE STILL IN THE BODY. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Blood Loss

  MAUDE report 8589480 ↗
• MalfunctionApr 27, 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. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR GLUCOSE VALUE AT THE TIME OF EVENT WAS 48 MG/DL. THE BLOOD GLUCOSE VALUE AT SUSPEND EVENT 110 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 8559307 ↗
• MalfunctionApr 16, 2019Incorrect, 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 64 MG/DL AT THE TIME OF THE INCIDENT. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE VALUES. SENSOR GLUCOSE VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 64 MG/DL. THRESHOLD/LOW SUSPEND LIMIT IN SENSOR SETTINGS WAS 70 MG/DL. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE DEVICE WAS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Blood Loss

  MAUDE report 8517412 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160017. One submission often covers many models, so check the product and lot details in each record.

• Z-2981-2026 · Jul 13, 2026 · Open, Classified
  MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
• Z-1742-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
• Z-1739-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
• Z-1261-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
• Z-1265-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
• Z-1266-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
• Z-0003-2025 · Jul 31, 2024 · Open, Classified
  MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G
• Z-0193-2023 · Sep 20, 2022 · Open, Classified
  Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742
• Z-0855-2022 · Jan 27, 2022 · Open, Classified
  MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-18
• Z-1771-2021 · Mar 15, 2021 · Open, Classified
  MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL; PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL; KIT MMT-1896WW MM780G 6.5W BLE
• Z-0516-2021 · Apr 30, 2020 · Open, Classified
  MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under
• Z-0956-2020 · Nov 21, 2019 · Open, Classified
  Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, and MM
• Z-2605-2017 · May 8, 2017 · Terminated
  MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.
• Z-2604-2017 · May 8, 2017 · Terminated
  MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1551, MMT-1751, MMT-1552, MMT-1752.