Guardian ™ Sensor (3) MMT-7020A (UDI 20763000118864)Recalls & reported problems

Summary

The FDA's MAUDE database contains 295 adverse event reports that list this exact device (DI 20763000118864), received between May 23, 2018 and Mar 30, 2020 — classified as 62 injuries, 233 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (131 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 295 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2020Fracture; Fracture

  CUSTOMER REPORTED VIA PHONE CALL HIGH BLOOD GLUCOSE LEVELS AND HOSPITALIZATION. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 507 MG/DL AND THEY WENT TO THE EMERGENCY ROOM. CUSTOMER WAS TREATED VIA MANUAL INJECTION. CUSTOMER ADVISED THE SENSOR CANNULA WAS STUCK INSIDE OF THEIR BODY BREAKING IN THEIR SKIN. THE INSULIN PUMP AND THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9900610 ↗
• InjuryMar 28, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED FOR HIGH BLOOD GLUCOSE AND SENSOR STUCK INSIDE BODY ON (B)(6) 2020. BLOOD GLUCOSE READING WAS 507 MG/DL. CUSTOMER WAS USING AUTO MODE. CUSTOMER WAS TREATED WITH MANUAL INJECTION AND FLUIDS IN THE EMERGENCY ROOM. CUSTOMER REPORTED THAT THEY DID RECEIVE MEDICAL TREATMENT AS A RESULT OF THE SENSOR FRACTURING WHILE STILL IN THE BODY. TROUBLESHOOTING WAS DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP AND SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Foreign Body In Patient; Hyperglycemia

  MAUDE report 9892540 ↗
• MalfunctionFeb 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 100 MG/DL AND SENSOR GLUCOSE WAS UNDER 50 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 9718641 ↗
• MalfunctionFeb 14, 2020Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE NEEDLE WAS BROKE ON THE RESERVOIR. CUSTOMER STATED THAT SENSOR WAS FALL OFF FROM THE BODY. CUSTOMER ALSO STATED THAT THE TAPE WAS STUCK TO THE BODY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9710053 ↗
• MalfunctionOct 24, 2019Break; Incorrect, Inadequate or Imprecise Result or Readings; Break; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR WAS STILL IN THE BODY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 148 MG/DL. CUSTOMER REPORTED THAT THEY DID NOT RECEIVED MEDICAL TREATMENT AS A RESULT OF THE SENSOR FRACTURING WHILE STILL IN THE BODY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Itching Sensation

  MAUDE report 9231199 ↗
• MalfunctionJul 18, 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. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE VALUES. SENSOR GLUCOSE VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 55 MG/DL. THRESHOLD/LOW SUSPEND LIMIT IN SENSOR SETTINGS WAS 90 MG/DL. THE BLOOD GLUCOSE VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 76 MG/DL. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. CUSTOMER REPORTS THEY DID RECEIVE A SENSOR UPDATING OR SENSOR GLUCOSE NOT AVAILABLE ALERT. CUSTOMER REPORTS THEY DID RECEIVE A CALIBRATION NOT ACCEPTED ALERT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8801634 ↗
• MalfunctionJun 25, 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 VALUE WAS 50 MG/DL AND THE SENSOR GLUCOSE WAS 94 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. THE CUSTOMER ALSO REPORTED OTHER BLOOD GLUCOSE VALUES SUCH AS 100 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 8730223 ↗
• MalfunctionJun 14, 2019Calibration Problem; Calibration Problem

  CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT TWO SENSORS DIED BACK TO BACK AFTER ONE DAY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTED THEY DID RECEIVE A CALIBRATION NOT ACCEPTED ALERT. CUSTOMER REPORTED THEY DID RECEIVE A CHANGE SENSOR ALERT. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8698899 ↗
• MalfunctionJun 3, 2019Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem

  THE CUSTOMER REPORTED THAT THE INSULIN PUMP SUSPENDED THE DELIVERY OF INSULIN DUE TO THE INCORRECT SENSOR GLUCOSE VALUES. BLOOD GLUCOSE LEVEL OF THE CUSTOMER WAS 118 MG/DL AND SENSOR GLUCOSE VALUE WAS 52 MG/DL. THE CUSTOMER DECLINED FOR THE TROUBLESHOOTING. THE SENSOR WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8665213 ↗
• MalfunctionMay 21, 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 140 MG/DL, 120 MG/DL AND THE SENSOR GLUCOSE WAS 40 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. CUSTOMER STATES THE SENSOR VALUE THAT TRIGGERED THE SUSPEND ON LOW OR SUSPEND BEFORE LOW EVENT WAS 40 MG/DL. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS NOT CHECK. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8629969 ↗
• MalfunctionMay 14, 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 280 MG/DL AND THE SENSOR GLUCOSE WAS 50 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS UNKNOWN. SUSPEND ON LOW 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 SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8606865 ↗
• MalfunctionMay 7, 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 183 MG/DL AND THE SENSOR GLUCOSE WAS 96 MG/DL AT THE TIME OF THE INCIDENT. SENSOR GLUCOSE AND BLOOD GLUCOSE DIFFERENCE WAS 87 MG/DL. TROUBLESHOOTING WAS DONE AND CUSTOMER STATED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. SENSOR GLUCOSE WAS LOWER THAN BLOOD GLUCOSE. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE VALUES. SENSOR GLUCOSE VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 96 MG/DL. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 100 MG/DL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8585379 ↗
• MalfunctionMay 1, 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 130 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 MG/DL. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 40 MG/DL. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WILL RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8568286 ↗
• MalfunctionMar 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Calibration Problem; Appropriate Device Problem Term/Code Not Available; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Calibration Problem; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 150 MG/DL AND THE SENSOR GLUCOSE WAS 70 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 70 MG/DL. SUSPEND ON LOW 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 SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8451961 ↗
• MalfunctionMar 22, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR HAD SENSOR ANOMALY AND BROKEN SENSOR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 150 MG/DL AND CURRENT BLOOD GLUCOSE VALUE WAS 86MG/DL. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8442512 ↗
• MalfunctionMar 17, 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 91 MG/DL AND THE SENSOR GLUCOSE WAS 40 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT INSULIN DELIVERY WAS SUSPENDED DUE TO SG VALUES AND SG VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 213 MG/DL AND 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 SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8427344 ↗
• MalfunctionMar 11, 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 118 MG/DL AND THE SENSOR GLUCOSE WAS 50 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 50 MG/DL. SUSPEND ON LOW 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 SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8410171 ↗
• MalfunctionMar 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 THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 170 MG/DL AND THE SENSOR GLUCOSE WAS 40 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. CUSTOMER STATES THE SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 70. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 40. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANG. CUSTOMER REPORTS THEY DID NOT RECEIVE A SENSOR UPDATING OR SENSOR GLUCOSE NOT AVAILABLE ALERT. CUSTOMER REPORTS THEY DID RECEIVE A CALIBRATION NOT ACCEPTED ALERT. CUSTOMER DID NOT REPORT CONSECUTIVE SENSOR ALERTS WITH DIFFERENT SENSORS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8389524 ↗
• MalfunctionFeb 19, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL TO HAVE EXPERIENCED SENSOR GLUCOSE VERSUS BLOOD GLUCOSE DIFFERENCES WITH THRESHOLD SUSPEND. CUSTOMER'S SENSOR GLUCOSE WAS 89 AND BLOOD GLUCOSE WAS 161 MG/DL. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER WAS ADVISED ON PROPER SENSOR USAGE AND CALIBRATION TECHNIQUES. CUSTOMER WAS ADVISED THAT SENSOR WOULD BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8352320 ↗
• MalfunctionFeb 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 VALUE WAS 117 MG/DL AND THE SENSOR GLUCOSE WAS 85 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. CUSTOMER STATES INSULIN PUMP WAS NOT WORKING. CUSTOMER REPORTS THEY DID NOT RECEIVE A SENSOR UPDATING ALERT. CUSTOMER REPORTS THEY DID NOT RECEIVE A CALIBRATION NOT ACCEPTED ALERT. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8304143 ↗
• MalfunctionFeb 1, 2019Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR HAD LOST SIGNAL. THE CUSTOMER¿S BLOOD GLUCOSE WAS 175 MG/DL. CUSTOMER ALSO STATED THAT THEY COULD NOT FIND SIGNAL. CUSTOMER STATED THAT THEY SHUT UP AUTO MODE. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8295502 ↗
• MalfunctionJan 15, 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 147 MG/DL AND THE SENSOR GLUCOSE WAS 56 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 56 MG/DL. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 75 MG/DL. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8250895 ↗
• 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 THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 100 MG/DL AND THE SENSOR GLUCOSE WAS 53 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 60 MG/DL. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 60 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 8238872 ↗
• MalfunctionJan 8, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NOT CALIBRATING PROPERLY WITH THE SENSOR, AS A RESULT THE CUSTOMER'S BLOOD GLUCOSE WAS 51MG/DL AT THE TIME OF THE INCIDENT. TROUBLESHOOTING WAS NOT PERFORMED FOR LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS, HOWEVER THE SENSOR WILL.

  Patient problems: Hypoglycemia

  MAUDE report 8229076 ↗
• MalfunctionJan 8, 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 VALUE WAS 139 MG/DL AND THE SENSOR GLUCOSE WAS 71 MG/DL AT THE TIME OF INCIDENT. 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 8225490 ↗

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-1739-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, 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-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-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-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-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-1881
• 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 SF M
• 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.