Paradigm® REAL-Time Revel™ MMT-723LNAS (UDI 00613994904485)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-723LNAS PRDGM INS V2.4 SK EN LN · Class 3
All models of Paradigm REAL-Time Revel (180)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is a Medtronic MiniMed Paradigm Revel insulin pump. Its 50 reports mostly describe pumps stopping or restarting on their own, blank or garbled screens, buttons that stop responding, batteries draining or being rejected, and insulin or reservoir problems, with some users reporting high or low blood sugar. The reports include 1 death, 10 injuries and 39 malfunctions. One open recall, started in February 2026, covers unintended over- or under-delivery of insulin when the pump sits higher or lower than the infusion site.
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
- 50
- Deaths reported
- 1
- Injuries reported
- 10
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00613994904485), received between May 5, 2017 and Jul 13, 2020 — classified as 1 death, 10 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (11 reports).
1 FDA recall record name this device's identifier, 1 still open.
13 other recalls cover devices cleared under the same FDA submission (P980022); 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.
Recalls naming this device
- Feb 13, 2026Class IIOpen, Classified
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Z-1750-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Displays Incorrect Message11
- Device Difficult to Program or Calibrate9
- No Display/Image9
- Patient Device Interaction Problem8
- Power Problem8
- Mechanical Problem7
- Adverse Event Without Identified Device or Use Problem4
- Battery Problem4
Patient problems
- No Consequences Or Impact To Patient33
- Hyperglycemia12
- Hypoglycemia5
- Coma1
- Death1
- Elevated Ketones/ Diabetic Ketoacidosis1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2020Device Alarm System; No Display/Image; Moisture or Humidity Problem; Device Alarm System; No Display/Image; Moisture or Humidity Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS EXPOSED TO WATER AND WAS NOT WORKING ANYMORE. CUSTOMER STATES THE INSULIN PUMP WAS VIBRATING WITHOUT AN ALARM OR ALERT AND SCREEN WAS PARTIAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10262751 ↗MalfunctionJun 10, 2020Premature Discharge of Battery; Premature Discharge of Battery
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. CUSTOMER WAS ABLE TO CLEAR ALARM. CUSTOMER WAS NOT ABLE TO COMPLETE REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10136612 ↗MalfunctionMar 20, 2020Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY SMELL INSULIN FROM INSIDE AND THINKS THAT THE RESERVOIR MAY LEAK. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE REWIND WAS LOUDER. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9858926 ↗MalfunctionFeb 12, 2020Computer Software Problem; Patient Device Interaction Problem; Computer Software Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP WAS NOT GETTING THE CORRECT INSULIN AND THAT THE RESERVOIR CONTAINER THREAD WAS CHIPPING OFF. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9698503 ↗MalfunctionDec 6, 2019Mechanical Problem; Use of Device Problem; Power Problem; Mechanical Problem; Use of Device Problem; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR AND INSULIN PUMP ERROR. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT THEY HAD TO COMPLETELY RESTART AFTER EVERY BATTERY CHANGE AND HAD TO RESET TIME AND DATE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9422390 ↗MalfunctionDec 3, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS OF THE INSULIN PUMP WERE LESS RESPONSIVE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE INSULIN PUMP HAD HAIRLINE CRACKED AND REJECTED BATTERY. CUSTOMER ALSO STATED THAT NO DELIVERY, GRINDING ON REWIND AND SLOWER ON REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9400311 ↗MalfunctionNov 16, 2019Electrical /Electronic Property Problem; Battery Problem; Electrical /Electronic Property Problem; Battery Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD E008 CODE AND A CODES A COUPLE TIMES HAD TO RESTART AND REPRIME THE INSULIN PUMP TO CLEAR ERROR CODE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD DIMINISHED BATTERY LIFE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9333119 ↗MalfunctionNov 13, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD UNRESPONSIVE BUTTONS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT GiVING FINAL AUDIBLE ALARM. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9313959 ↗MalfunctionNov 6, 2019Failure to Cycle; Priming Problem; Failure to Cycle; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM DURING PRIME. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 145 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT INSULIN SQUIRTED OUT DURING MANUAL PRIMING. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT DROPPED OR BUMPED PRIOR TO THE ALARM OCCURRING. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL OR RECESSED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9288463 ↗MalfunctionOct 2, 2019Premature Discharge of Battery; Adverse Event Without Identified Device or Use Problem; Premature Discharge of Battery; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 137 MG/DL. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WAS ABLE TO CLEAR THE ALARM. THE CUSTOMER REPORTED THAT ANOTHER ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. THE CUSTOMER REPORTED THAT THE PUMP WAS STORED OR NOT IN USE FOR AN EXTENDED PERIOD OF TIME. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9143756 ↗MalfunctionAug 29, 2019Device Alarm System; Display or Visual Feedback Problem; Mechanical Problem; Date/Time-Related Software Problem; Power Problem; Device Alarm System; Display or Visual Feedback Problem; Mechanical Problem; Date/Time-Related Software Problem; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR, ALARM WAS NOT LOUD, DISCOLORATION ON SCREEN AND CLOCK WAS SLOW. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE REJECTED NEW BATTERIES. CUSTOMER DECLINED ALL TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8943325 ↗MalfunctionJul 9, 2019No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THEY CHANGED THE BATTERY AND AFTER INSERTING THE NEW ONE INSULIN PUMP STOPPED WORKING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER DID NOT CALLING BACK AFTER RECEIVING A NEW BATTERY CAP. CUSTOMER STATED THAT THE INSULIN PUMP HAD A LITTLE CRACK ON THE SIDE WHERE THE RESERVOIR COMPARTMENT WAS IN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8770602 ↗MalfunctionJun 27, 2019Device Alarm System; Mechanical Problem; Battery Problem; Power Problem; Patient Device Interaction Problem; Device Alarm System; Mechanical Problem; Battery Problem; Power Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR LIP RING WAS DAMAGED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 200 MG/DL. THE CUSTOMER STATED THAT INSULIN PUMP WAS REJECTED THE NEW BATTERY, REWIND WAS LOUDER,EDGE OF THE INSULIN PUMP WHERE THE RESERVOIR INSERTED WAS ROUGH. THE CUSTOMER STATED THAT CLOCK WAS OFF. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8738887 ↗MalfunctionJun 20, 2019Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED A MOTOR ERROR ALARM AND CHANGED THE BATTERY AND WAS NOT ABLE TO REWIND. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE PUMP REWIND. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND WAS ADVISED TO REFER TO BACK UP PLAN, PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8715927 ↗MalfunctionJun 12, 2019Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP'S BUTT. THE CUSTOMER¿S BLOOD GLUCOSE WAS 115 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTS THEY RECEIVED WEAK BATTERY AND LOW BATTERY ALERT. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8690091 ↗MalfunctionMay 21, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT HIS INSULIN PUMP HAD A KEYPAD ANOMALY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 142 MG/DL. THE CUSTOMER REPORTED THAT THE BUTTONS ON THE INSULIN PUMP WERE NOT WORKING. THE CUSTOMER WAS ASSISTED IN TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8626527 ↗MalfunctionMay 16, 2019Device Difficult to Program or Calibrate; Date/Time-Related Software Problem; Device Difficult to Program or Calibrate; Date/Time-Related Software Problem
CUSTOMER'S FAMILY REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD ESC THE KEYPAD NOT WORKING. IT WAS ALSO STATED THAT THE INSULIN PUMP HAD INSULIN PUMP TIME ADVANCED FORWARD. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8614776 ↗MalfunctionApr 17, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THEIR SON INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 206 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT WORKING AND ALL BUTTONS WERE NOT WORKING. THE CUSTOMER REPORTED THAT THE TIME CLOCK WAS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8521553 ↗MalfunctionApr 11, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS EXPOSED MOISTURE AND THEN ALARMED BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND THEY STATED THAT THE TIME WAS ADVANCES. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8502744 ↗MalfunctionApr 3, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP ACT BUTTON NOT WORKING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATES PERIODICALLY THE INSULIN PUMP WILL STOP PUMPING INSULIN OUT. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8477616 ↗MalfunctionMar 27, 2019No Display/Image; Adverse Event Without Identified Device or Use Problem; No Display/Image; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND THE DISPLAY DID NOT RETURN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8455061 ↗MalfunctionMar 20, 2019Device Difficult to Program or Calibrate; Wireless Communication Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Wireless Communication Problem; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD UNRESPONSIVE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE BUTTONS WERE NOT WORKING PROPERLY. CUSTOMER ALSO STATED THAT THEY RECEIVED THE PUMP ERROR FREQUENTLY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8435583 ↗MalfunctionFeb 15, 2019Premature Discharge of Battery; Connection Problem; Patient Device Interaction Problem; Unexpected Shutdown; Premature Discharge of Battery; Connection Problem; Patient Device Interaction Problem; Unexpected Shutdown
CUSTOMER REPORTED VIA PHONE CALL THAT THE TOP PART OF THE RESERVOIR COMPARTMENT HAS BROKEN OFF AND HAD A PUMP ERROR ALARMS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 232 MG/DL. CUSTOMER REPORTS THAT RESERVOIR WAS UNABLE TO LOCK IN PLACE. CUSTOMER WAS ADVISED TO REVERT TO BACKUP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8342947 ↗MalfunctionJan 21, 2019Premature Discharge of Battery; Unexpected Shutdown; Premature Discharge of Battery; Unexpected Shutdown
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD MULTIPLE PUMP ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR THE ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8263497 ↗MalfunctionNov 30, 2018Power Problem; Power Problem
CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD OFF NO POWER ALARM WITHOUT LOW BATTERY ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS 190 MG/DL AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8119064 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P980022. One submission often covers many models, so check the product and lot details in each record.
- Z-1749-2026 · Feb 13, 2026 · Open, ClassifiedParadigm REAL-Time Insulin Pump (MMT-522, MMT-722)
- Z-1256-2025 · Jan 31, 2025 · Open, ClassifiedParadigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
- Z-1587-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522
- Z-1591-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523
- Z-1593-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723K
- Z-1592-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523K
- Z-1590-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722K
- Z-1589-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522K
- Z-1594-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723
- Z-1588-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722
- Z-2442-2015 · Jul 22, 2015 · TerminatedGuardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with d
- Z-2179-2014 · Jul 21, 2014 · TerminatedMedtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combinatio
- Z-2544-2014 · Mar 13, 2014 · TerminatedMedtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K
Other Sensor, glucose, invasive devices
- Dexcom G4 Platinum Sensor 9500-27Dexcom, Inc. · Sensor, Glucose, Invasive2 recalls2 deaths99,426 reports
- Dexcom G5 Transmitter Kit STT-GF-001Dexcom, Inc. · Sensor, Glucose, Invasive1 death58,932 reports
- Dexcom G5 Mobile IOS App SW10611Dexcom, Inc. · Sensor, Glucose, Invasive54,544 reports
- Dexcom G5 Transmitter 9438-06Dexcom, Inc. · Sensor, Glucose, Invasive15,360 reports
- Dexcom G5 Mobile Receiver MT22719Dexcom, Inc. · Sensor, Glucose, Invasive1 death12,594 reports
- Dexcom G4 SBT Transmitter 9438-05Dexcom, Inc. · Sensor, Glucose, Invasive1 death9,041 reports
- Dexcom G5 Mobile Receiver MT22719-BLUDexcom, Inc. · Sensor, Glucose, Invasive7,685 reports
- Dexcom G5 Mobile Receiver Kit STK-GF-001Dexcom, Inc. · Sensor, Glucose, Invasive1 recall6,345 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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