Guardian ™ Sensor (3) MMT-7020B (UDI 00763000017569)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000017569), received between May 4, 2018 and Aug 29, 2018 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

22 other recalls cover devices cleared under the same FDA submission (P150001, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2018No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 522 MG/DL AT THE TIME OF INCIDENT. CUSTOMER TREATED WITH INSULIN PUMP AND MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Foreign Body In Patient; Hyperglycemia

  MAUDE report 7827282 ↗
• MalfunctionJul 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SENSOR HAD AN UNEXPECTED INSULIN FLOW BLOCKED ANOMALY AND THE SENSOR GLUCOSE VALUE AND BLOOD GLUCOSE VALUE SEEMED INCORRECT. BLOOD GLUCOSE VALUE WAS 358 MG/DL AT THE TIME OF THE INCIDENT. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS ADVISED TO TRY INSERTING HER SENSOR THE DAY BEFORE TO ALLOW CANNULA TO BE FULLY SATURATED IN HER INFUSION SET. NOTHING WILL BE REPLACED OR RETURNED.

  Patient problems: Hyperglycemia

  MAUDE report 7671829 ↗
• InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL AS WELL AS HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER'S LOW BLOOD GLUCOSE LEVEL WAS 45 MG/DL. THE CUSTOMER'S HIGH BLOOD GLUCOSE LEVEL WAS 406 MG/DL, 400 MG/DL AND .506 MG/DL. THE CUSTOMER WAS TREATED BY THE JUICE FOR THE LOW BLOOD GLUCOSE LEVEL AND BY MANUAL INJECTIONS FOR HIGH BLOOD GLUCOSE LEVEL. OTHER RELEVANT BLOOD GLUCOSE LEVEL OF THE CUSTOMER WAS 116 MG/DL. THE CUSTOMER DECLINED TO TROUBLESHOOTING FOR BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS AND SENSOR WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 7632916 ↗
• InjuryJun 22, 2018Failure to Deliver

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE WAS 520 MG/DL AND 117 MG/DL. THE CUSTOMER REPORTED THAT THEY HAD NO DELIVERY. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE AND NO DELIVERY. THE CUSTOMER WAS ADVISED TO RETURN THE SENSOR. THE SENSOR WILL BE AND INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7631931 ↗
• InjuryJun 6, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 51MG/DL, 168MG/DL, 156MG/DL. THE CUSTOMER WAS TREATED WITH JUICE. THE CUSTOMER DECLINED TROUBLESHOOT FOR LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7572325 ↗
• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 47 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR LOW BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH FOOD. CUSTOMER WILL NOT RETURNED DEVICE FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7559684 ↗
• InjuryMay 15, 2018Incorrect Or Inadequate Test Results

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 480 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTION. THE CUSTOMER ALSO REPORTED SENSOR WITH INACCURATE READINGS. BLOOD GLUCOSE WAS 480 MG/DL WHILE SENSOR GLUCOSE WAS 318 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH READINGS AND SENSOR ISSUES. THE INSULIN PUMP/SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7517105 ↗
• MalfunctionMay 4, 2018Incorrect, Inadequate or Imprecise Result or Readings; Device Displays Incorrect Message

  THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM AND CUSTOMER EXPERIENCED THE HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 410 MG/DL AND SENSOR GLUCOSE WAS 136 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 178 MG/DL AND SENSOR BLOOD GLUCOSE LEVEL WAS 296 MG/DL. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7486143 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150001, 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-1740-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• 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-1259-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• 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-0001-2025 · Jul 31, 2024 · Open, Classified
  MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
• 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-0517-2021 · Apr 30, 2020 · Open, Classified
  MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rate
• 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

…and 7 more.