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Guardian ™ Sensor (3) MMT-7020A (UDI 20643169704057)Recalls & reported problems

Medtronic Minimed, Inc. · SENSOR MMT-7020A ENLITE3 5PK 2L US · Class 3

All models of Guardian Sensor (3) (11)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Medtronic MiniMed Guardian glucose sensor is part of an artificial pancreas system. Its 716 reports, with 274 injuries and no deaths, mostly describe inaccurate sensor readings, incorrect messages on the device and test results that do not match. Patients in these reports mention high and low blood sugar, and some describe inaccurate readings that led to insulin delivery being suspended. No recalls name this device, and there were no reports in the last 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
716
Deaths reported
0
Injuries reported
274
Recalls naming it
0

Summary

The FDA's MAUDE database contains 716 adverse event reports that list this exact device (DI 20643169704057), received between Jun 28, 2017 and Jul 15, 2022 — classified as 274 injuries, 442 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (197 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

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings197
  • Device Displays Incorrect Message164
  • Incorrect Or Inadequate Test Results106
  • Device Operates Differently Than Expected59
  • Insufficient Device Problem Information58
  • Adverse Event Without Identified Device or Use Problem55
  • Calibration Problem51
  • False Reading From Device Non-Compliance23

Patient problems

  • No Consequences Or Impact To Patient312
  • Hyperglycemia212
  • Hypoglycemia158
  • Blood Loss68
  • Skin Irritation17
  • Rash8
  • Pain7
  • Itching Sensation6

Recent adverse event reports

The 25 most recent of 716 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 15, 2022Manufacturing, Packaging or Shipping Problem; Material Integrity Problem; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem

    MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15025143 ↗
  • MalfunctionFeb 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Activation Problem; Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Activation Problem

    INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A THRESHOLD SUSPEND. THE CUSTOMER¿S BLOOD GLUCOSE WAS 130 MG/DL AND SENSOR GLUCOSE WAS 80 MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE IS OUTSIDE THE ACCEPTABLE RANGE. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS AT 65 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 9688299 ↗
  • MalfunctionJul 10, 2019Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Calibration Problem; Material Twisted/Bent; No Apparent Adverse Event; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Calibration Problem; Material Twisted/Bent; No Apparent Adverse Event

    CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 237 MG/DL AND THE SENSOR GLUCOSE WAS 46 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 46 MG/DL. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 70. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANG. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8777550 ↗
  • MalfunctionMay 18, 2019Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem

    THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THE SENSOR HAD SENSOR FAIL. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8622168 ↗
  • MalfunctionApr 23, 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 RECEIVED CALIBRATION NOT ACCEPTED, SENSOR UPDATING OR SENSOR GLUCOSE NOT AVAILABLE AND ALSO CHANGE SENSOR ALERT. TROUBLESHOOTING WAS DECLINED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. SENSOR WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8540217 ↗
  • InjuryMar 18, 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 122 MG/DL AND THE SENSOR GLUCOSE WAS 42 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 42 MG/DL. THRESHOLD/LOW SUSPEND LIMIT IN SENSOR SETTING WAS 70 MG/DL. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. CUSTOMER ALSO MENTIONED BLOOD AT SITE. THE DEVICE WAS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

    Patient problems: Blood Loss

    MAUDE report 8429475 ↗
  • MalfunctionFeb 11, 2019Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem

    CUSTOMER REPORTED VIA THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 82MG/DL AND THE SENSOR GLUCOSE WAS 50MG/DL INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 52MG/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 8329292 ↗
  • MalfunctionJan 16, 2019Communication or Transmission Problem; Communication or Transmission Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR HAD SENSOR ISSUE. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8251848 ↗
  • MalfunctionDec 4, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR HAD SENSOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 143 MG/DL. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8127700 ↗
  • MalfunctionNov 23, 2018Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER REPORTED VIA PHONE THAT SENSOR WENT ON SENSOR UPDATING THEN CHANGE SENSOR, WHEN HE REMOVED IT ITS A BIT CURVED SENSOR UPDATING (GUARDIAN SENSOR 3). THE SENSOR WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8099589 ↗
  • InjuryNov 13, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE WITH BLOOD GLUCOSE OF 65 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS GIVEN JUICE AND FOOD TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER HAD SENSOR GLUCOSE VERSUS BLOOD GLUCOSE DIFFERENCES. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 8063154 ↗
  • MalfunctionNov 7, 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 160 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 70 MG/DL. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8049337 ↗
  • MalfunctionNov 2, 2018Calibration Problem; Calibration Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 108 MG/DL AND THE SENSOR GLUCOSE WAS 48 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 WAS RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8033737 ↗
  • MalfunctionNov 2, 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 BLOOD GLUCOSE WAS 162MG/DL AND 128MG/DL AND THE SENSOR GLUCOSE WAS 61 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 61MG/DL. THRESHOLD SUSPEND LIMIT IN SENSOR SETTINGS 65MG/DL. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8031895 ↗
  • MalfunctionNov 1, 2018Unexpected Therapeutic Results; 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 141 MG/DL AND THE SENSOR GLUCOSE WAS 89 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 59 MG/DL. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 70 MG/DL AND 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 8027148 ↗
  • MalfunctionOct 29, 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 232 MG/DL AND THE SENSOR GLUCOSE WAS 119 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 8014746 ↗
  • MalfunctionOct 26, 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 186 MG/DL AND THE SENSOR GLUCOSE WAS 69MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 117. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. CUSTOMER REPORTED THEY DID RECEIVE A CALIBRATION NOT ACCEPTED ALERT. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8008098 ↗
  • MalfunctionOct 25, 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 WAS 140 MG/DL AND THE SENSOR GLUCOSE WAS 56 MG/DL. THE SENSOR GLUCOSE VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 88 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 RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8004899 ↗
  • InjuryOct 19, 2018Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

    CUSTOMER REPORTED VIA PHONE CALL SENSOR ANOMALY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ADVISED THE SENSOR WAS MISSING AN ELECTRODE. CUSTOMER WAS ADVISED TO RETURN THE SENSOR AND THAT A REPLACEMENT SENSOR WOULD BE SENT OUT. SENSOR WILL BE RETURN FOR ANALYSIS.

    Patient problems: Blood Loss; Unspecified Infection

    MAUDE report 7983963 ↗
  • MalfunctionOct 19, 2018Break; Break

    CUSTOMER REPORTED VIA PHONE CALL SENSOR ANOMALY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 128 MG/DL. CUSTOMER ADVISED THEY EXPERIENCED ISSUES WITH THE SENSOR. CUSTOMER WAS ADVISED TO RETURN THE SENSOR AND THAT A REPLACEMENT SENSOR WOULD BE SENT OUT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7983777 ↗
  • MalfunctionOct 17, 2018Unexpected Therapeutic Results; 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 102 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 UNKNOWN. 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 BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7973169 ↗
  • MalfunctionOct 10, 2018Break; Break

    THE CUSTOMER REPORTED VIA PHONE CALL SENSOR ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER ADVISED THEIR SENSORS DID NOT FUNCTION PROPERLY. THE CUSTOMER WAS ADVISED TO RETURN THE SENSORS FOR ANALYSIS AND THAT REPLACEMENT SENSORS WOULD BE SENT OUT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7950450 ↗
  • MalfunctionOct 8, 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 117 MG/DL. SENSOR GLUCOSE LEVEL AT THE TRIGGERED SUSPEND EVENT WAS 80 MG/DL. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE VALUES. SENSOR GLUCOSE VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 80 MG/DL. THRESHOLD AND LOW SUSPEND 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 7943367 ↗
  • MalfunctionOct 4, 2018Calibration Problem; Calibration Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INTRODUCER NEEDLE WAS FRACTURE WHILE IN THE BODY. CUSTOMER¿S BLOOD GLUCOSE WAS 144 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTS THAT THEY DID NOT RECEIVE MEDICAL TREATMENT AS A RESULT OF THE NEEDLE FRACTURING WHILE STILL IN THE BODY. SENSOR WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Discomfort

    MAUDE report 7936448 ↗
  • InjuryOct 2, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED A MEDICAL INTERVENTION ON (B)(6) 2018 FOR A LOW BLOOD GLUCOSE OF 21 MG/DL DESPITE A SENSOR GLUCOSE OF 122 MG/DL. PRIOR TO THE MEDICAL TREATMENT, THE CUSTOMER WAS IN BED AND HAD A SEIZURE DUE TO THE HYPOGLYCEMIA. EMS ARRIVED ON SCENE AND TREATED THE CUSTOMER WITH A GLUCAGON SHOT. TROUBLESHOOTING WAS INITIATED FOR THE SENSOR GLUCOSE INACCURACY BUT WAS INCONCLUSIVE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 21 MG/DL AND THE SENSOR GLUCOSE WAS 122 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ALSO REPORTING SOME SENSORS THAT WERE APPROXIMATELY 100 POINTS OFF FROM THE BLOOD GLUCOSE. IT IS UNKNOWN IF THE AUTO MODE FEATURE WAS ACTIVE DURING THE HYPOGLYCEMIC INCIDENT. THE INSULIN PUMP IS EXPECTED TO RETURN FOR ANALYSIS. THE SENSOR IS ALSO EXPECTED TO RETURN FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 7928951 ↗

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-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-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.
  • Z-2605-2017 · May 8, 2017 · Terminated
    MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.

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