Guardian Sensor (3)Recalls & reported problems across all models

We found 11 models of Guardian Sensor (3) by Medtronic Minimed, Inc. in the FDA's device registry (GUDID). Together they are named in 2,726 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2017 and Jul 15, 2022 — classified as 657 injuries, 2,069 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1,414 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Guardian Sensor (3) problems

Guardian Sensor (3) models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Guardian™ Sensor (3) MMT-7020A

  Automated insulin dosing device system, single hormonal control
  1,304 reports
• Guardian ™ Sensor (3) MMT-7020A

  Artificial pancreas device system, single hormonal control
  716 reports
• Guardian ™ Sensor (3) MMT-7020A

  Automated insulin dosing device system, single hormonal control
  329 reports
• Guardian ™ Sensor (3) MMT-7020A

  Automated insulin dosing device system, single hormonal control
  295 reports
• Guardian™ Sensor (3) MMT-7020B

  Automated insulin dosing , threshold suspend
  36 reports
• Guardian ™ Sensor (3) MMT-7020B

  Artificial pancreas device system, single hormonal control
  26 reports
• Guardian ™ Sensor (3) MMT-7020B

  Sensor, glucose, invasive
  8 reports
• Guardian™ Sensor (3) MMT-7020A

  Automated insulin dosing , threshold suspend
  6 reports
• Guardian™ Sensor (3) MMT-7020A

  Automated insulin dosing device system, single hormonal control
  4 reports
• Guardian ™ Sensor (3) MMT-7020B

  Automated insulin dosing device system, single hormonal control
  1 report
• Guardian™ Sensor (3) MMT-7020LA

  Automated insulin dosing device system, single hormonal control
  1 report

Recent Guardian Sensor (3) adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJun 30, 2022Calibration Problem; Calibration Problem

  MEDTRONIC RECEIVED INFORMATION THAT BATTERY CAP CRACKED/DAMAGED 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 14876841 ↗
• MalfunctionMar 16, 2022Therapeutic or Diagnostic Output Failure

  I AM USING A MEDTRONIC 670G WITH THE GUARDIAN 3 SENSORS FOR GLUCOSE MONITORING AND CONTROL. I HAVE BEEN EXPERIENCING AN EXTREME FAILURE RATE WITH THE GUARDIAN 3 SENSORS. THE MAIN PROBLEM BEGINS WITH THE INSERTION AND CALIBRATION OF THE SENSOR. THE INSERTION AND THE FIRST CALIBRATION GO WELL BUT STARTING WITHIN 2 HOURS THE REPORTED GLUCOSE VALUES WILL BE WELL OUTSIDE OF AN ACCEPTABLE ERROR RANGE, (SENSOR REPORTING 54, BLOOD GLUCOSE FINGER STICK READING 107 FOR ONE EXAMPLE). DURING THE 2-48 HOUR INSERTION WINDOW THE ACCURACY RANGE OF THE SENSOR VARIES FOR LESS THAN 5% TO WELL OVER 50%. SINCE THIS DEVICE IS DELIVERING INSULIN DEPENDING ON THE INFORMATION FROM THE SENSOR, THIS CAN CAUSE LIFE THREATENING ISSUES. IF THE SENSOR WERE TO READ HIGH AND DELIVER WHAT IT BELIEVED TO BE A CORRECTING BOLUS OF INSULIN AND I WAS ACTUALLY IN A LOW GLUCOSE SITUATION THIS WOULD BE LIFE THREATENING. THIS HAS BEEN AN ONGOING ISSUE WITH THE GUARDIAN 3 SENSOR SINCE I MOVED OVER TO THIS SYSTEM LAST OCTOBER. MULTIPLE CONVERSATIONS WITH MEDTRONIC AND MY ENDOCRINOLOGIST HAVE FAILED TO RESOLVE THE ISSUE. I HAVE WENT THROUGH MULTIPLE LAYERS OF TROUBLE SHOOTING WITH MEDTRONIC TECH SUPPORT, THEY REPLACED THE GUAR

  Patient problems: Insufficient Information

  MAUDE report 13798008 ↗
• MalfunctionJul 20, 2021Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INTRODUCES NEEDLE FRACTURED WHILE IN THE BODY. CUSTOMER MENTIONED THAT SENSOR FELL OFF RIGHT AFTER INSERTION. CUSTOMER STATED THAT THE ISSUE WAS OCCURRED PRIOR TO INSERTION. CUSTOMER STATED THAT THE NEEDLE WAS DETACHED. CUSTOMER REPORTED THE SENSOR WAS NO LONGER IN THE BODY. CUSTOMER REPORTED THAT THEY DID NOT RECEIVE MEDICAL TREATMENT AS A RESULT OF THE SENSOR FRACTURING WHILE STILL IN THE BODY. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194896 ↗
• MalfunctionMar 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Therapeutic or Diagnostic Output Failure

  MEDTRONIC GUARDIAN SENSOR (3) FAILED. INSERTED A NEW SENSOR ON THE MORNING OF (B)(6) 2021 AND WAS GOING THROUGH THE CALIBRATION PROCESS. THE SENSOR READING AT 9:01 PM WAS 113 AND MY ACTUAL BG WAS 193. I HAVE NOW HAD 6 OUT OF 9 SENSORS OF LOT HG50LUF (REF (B)(4)) FAIL. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Hyperglycemia

  MAUDE report 11568461 ↗
• InjuryMar 16, 2021Activation, Positioning or Separation Problem

  I WAS SETTING UP TO INSERT A NEW MEDTRONIC GUARDIAN SENSOR (3) WHEN A CLEAR PLASTIC PART OF THE SENSOR DID NOT SEPARATE FROM THE TAP. I HAVE HAD SEVERAL ISSUES WITH THIS LOT NUMBER OF SENSOR SO I DID NOT WANT TO USE THE SENSOR AND HAVE IT FAIL. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11506763 ↗
• MalfunctionMar 16, 2021Low Test Results; Separation Failure

  THIS IS THE SECOND SENSOR THAT I HAD TO REPLACE TODAY (MEDTRONIC GUARDIAN SENSOR (3)). DURING CALIBRATION, SENSOR WAS READING 72 ACTUAL BLOOD SUGAR WAS 111. SENSOR WAS READING BETWEEN 60-72 FOR 2 HOURS. I HAVE CONTACTED MEDTRONIC SEVERAL TIME BECAUSE I BELIEVE THAT THERE IS AN ISSUE WITH LOT HG50LUF. I HAVE THREE BOXES OF THIS SAME LOT NUMBER, THREE SENSOR OF THE FIRST BOX FAILED AND NOW 2 SENSORS OF THE SECOND BOX. I AM SENDING THE SENSOR WHERE THE CLEAR PLASTIC PART DID NOT SEPARATE FROM THE TAP BACK TO MEDTRONIC AS WELL AS THE REMAINING TWO SENSORS IN THE BOX. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11505326 ↗
• MalfunctionMar 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Material Twisted/Bent

  SENSOR FAILURE OF MEDTRONIC GUARDIAN SENSOR (3). WAS NOT READING BG ACCURATELY FILAMENT WAS BENT. REF - MMT-7020A. DID NOT REPLACE SENSOR WITH A NEW ONE AS I HAD INSERTED ONE ON (B)(6) 2021 THAT FAILED, THIS WAS THE SECOND ONE THAT I INSERTED. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11412699 ↗
• MalfunctionMar 2, 2021Therapeutic or Diagnostic Output Failure

  INSERTED NEW MEDTRONIC GUARDIAN SENSOR (3) IN THE MORNING AND ABOUT 5 HOURS LATER I HAD TO REPLACE THE SENSOR DUE TO SENSOR FAILURE. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11404365 ↗
• MalfunctionAug 13, 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 188 MG/DL AND SENSOR GLUCOSE WAS 86 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 10400302 ↗
• MalfunctionAug 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 91MG/DL AND THE SENSOR GLUCOSE WAS 40 MG/DL. INSULIN DELIVERY WAS SUSPEND DUE TO SENSOR VALUES. CUSTOMER STATED INSULIN PUMP RECEIVED CALIBRATION NOT ACCEPTED AND CHANGE SENOR ALERT. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10384244 ↗
• MalfunctionAug 7, 2020Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem; Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 124 MG/DL AND THE SENSOR GLUCOSE WAS 64 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. 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 10377343 ↗
• MalfunctionAug 6, 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 150 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 10372239 ↗
• InjuryAug 6, 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 145 MG/DL AND SENSOR GLUCOSE WAS 45 MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE IS OUTSIDE THE ACCEPTABLE RANGE. CUSTOMER STATED DIFFERENCE WAS 100 POINTS OFF. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10371513 ↗
• MalfunctionAug 4, 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 120 MG/DL AND SENSOR GLUCOSE WAS 66 MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE WAS OUTSIDE THE ACCEPTABLE RANGE. SENSOR GLUCOSE LEVEL AND BLOOD GLUCOSE LEVEL DIFFERENCE WAS 54 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 10361132 ↗

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