Paradigm® REAL-Time Revel™ MMT-523NAB (UDI 00613994743848)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-523NAB PRDGM INS V2.3 BL EN · Class 3
All models of Paradigm REAL-Time Revel (180)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Paradigm Real-Time Revel insulin pump is described in reports involving motor errors, alarms, battery and button problems, reservoir damage, and interruptions in insulin delivery, sometimes with high blood sugar. There are 23 reports, including 1 death and 7 injuries. No recalls name this device.
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
- 23
- Deaths reported
- 1
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00613994743848), received between May 31, 2017 and Jun 25, 2020 — classified as 1 death, 7 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (7 reports).
14 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.
Most reported problems
Device problems
- Device Displays Incorrect Message7
- Mechanical Problem7
- Failure to Deliver3
- Patient Device Interaction Problem3
- Adverse Event Without Identified Device or Use Problem2
- Device Difficult to Program or Calibrate2
- Inappropriate or Unexpected Reset2
- Material Protrusion/Extrusion2
Patient problems
- No Consequences Or Impact To Patient11
- Hyperglycemia10
- Coma1
- Death1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2020Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 564 MG/DL. CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER STATED INSULIN PUMP HAD MOTOR ERROR ALARM AND WAS ABLE TO REWIND INSULIN PUMP. CUSTOMER STATED DRIVE SUPPORT CAP APPEARS NORMAL. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 10193723 ↗MalfunctionMay 11, 2020Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER WAS ABLE TO COMPLETE REWIND. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10044093 ↗MalfunctionFeb 4, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEY COULD NOT PUT IN BATTERY INSIDE THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9669075 ↗MalfunctionJan 7, 2020Premature Discharge of Battery; Patient Device Interaction Problem; Premature Discharge of Battery; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS REPORTED THAT THE RESERVOIR RING CAME OFF AND HAD CRACK ON CORNER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9556872 ↗MalfunctionNov 4, 2019Mechanical Problem; Battery Problem; Priming Problem; Mechanical Problem; Battery Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED INSULIN SQUIRTED FROM INFUSION SET WHEN PRIMING AND INSULIN PUMP REWIND MORE THAN ONCE. CUSTOMER ALSO STATED BATTERY LIFE WAS DIMINISHED BUT NOT LESS THAN 7 DAYS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9276060 ↗MalfunctionJun 6, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE UP AND DOWN BUTTONS WERE HARDER TO PRESS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8673512 ↗MalfunctionMay 16, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY, NO DELIVERY AND MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 162 MG/DL. THE CUSTOMER REPORTED THAT THE UP AND DOWN BUTTONS WERE HARD TO RESPOND AND ALSO HAD NO DELIVERY ALARM. THE CUSTOMER REPORTED THAT HE EVENT WAS RESOLVED BY CHANGING COMPLETE SET (INFUSION SET AND RESERVOIR). CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. 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 8614883 ↗DeathJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2018. THE CAUSE OF DEATH WAS ANOXIC ENCEPHALOPATHY AND ASPIRATION PNEUMONIA. THE CALLER STATED THAT THE CUSTOMER HAD A DIABETIC COMA WHEN THEY FELL, THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE FALL. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE INSULIN PUMP HAD BEEN DISCONNECTED MORE THAN 48 HOURS PRIOR TO PASSING. THE CUSTOMER WAS NOT USING SENSORS. THE CUSTOMER'S INSULIN PUMP GOT BROKEN WHEN THEY FELL. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. FRN-UNK-RSVR. UNOMED SET.
Patient problems: Coma; Death
MAUDE report 8239121 ↗MalfunctionDec 8, 2018No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT SCREEN WAS HARD TO READ. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8144735 ↗InjuryAug 22, 2018No Apparent Adverse Event; No Apparent Adverse Event
CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP EXPERIENCED A NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 600 MG/DL AT THE TIME OF THE INCIDENT. TROUBLESHOOTING WAS DONE AND WAS ADVISED THAT SET MIGHT BE OCCLUDED. THE INFUSION SET WILL BE REPLACED AND RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7807666 ↗InjuryAug 7, 2018Device Alarm System; Device Alarm System
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 400 MG/DL AT THE TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE WAS 300 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. CUSTOMER WILL NOT BE RETURNED DEVICE FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7755740 ↗MalfunctionJul 6, 2018Power Problem; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED NO DELIVERY ALARM AND LOW BATTERY ALERT GREATER THAN 1 WEEK. CUSTOMER CANNOT RECALL THEIR BLOOD GLUCOSE READING. TROUBLESHOOTING WAS NOT PERFORMED. INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7667782 ↗MalfunctionJun 15, 2018Crack
THE CUSTOMER REPORTED VIA PHONE CALL THAT THERE WAS A CRACK IN RESERVOIR COMPARTMENT. BLOOD GLUCOSE WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. RING OF THE RESERVOIR WAS UNABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7604478 ↗InjuryMay 31, 2018Bent
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS ON (B)(6) 2018 WITH UNKNOWN BLOOD GLUCOSE. THE CUSTOMER REPORTED THAT THEY WERE CALLED DUE TO BENT CANNULAS. THE CUSTOMER WAS TREATED BY INSULIN DRIP. TROUBLESHOOTING WAS DECLINED FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS UNSURE ABOUT WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7555712 ↗MalfunctionMar 23, 2018Fluid/Blood Leak; Device Displays Incorrect Message; Material Protrusion/Extrusion
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM AND INSULIN WAS SQUIRTING OUT DURING MANUAL PRIME. THE CUSTOMER'S BLOOD GLUCOSE WAS 267 MG/DL. THE DRIVE SUPPORT CAP WAS PROTRUDED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7367923 ↗MalfunctionFeb 13, 2018Retraction Problem; Device Displays Incorrect Message; Material Protrusion/Extrusion
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 180 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP IS NOT REWINDING ANYMORE IT' WAS SAYING COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER STATES THE DRIVE SUPPORT CAP IS STICKING 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 CUSTOMER DECLINED TO RETURN THE INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7268568 ↗MalfunctionSep 20, 2017Failure to Deliver; Device Displays Incorrect Message; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP DELIVERED AN UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 138 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THEY RECEIVED THE ALARM MULTIPLE TIMES AFTER CHANGING THE BATTERY. TROUBLESHOOTING WAS PERFORMED AND IT WAS DETERMINED THE INSULIN PUMP NEEDS TO BE REPLACED. THE CUSTOMER WAS ADVISED A REPLACEMENT INSULIN PUMP WILL BE SENT OUT AND TO USE A BACKUP PLAN PER HEALTHCARE PROFESSIONAL'S RECOMMENDATION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6881725 ↗InjuryAug 25, 2017Mechanical Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED A HIGH BLOOD GLUCOSE LEVEL OF 487 MG/DL. THE CUSTOMER REPORTED A BOLUS DELIVERY AND IT REWOUND ITSELF. THE CUSTOMER DID NOT TROUBLESHOOT THE ISSUES. THE CUSTOMER REPORTED REOCCURRING BOLUS STOPPED ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 6820932 ↗MalfunctionJul 6, 2017Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 77 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. THE CUSTOMER STATES THE INSULIN PUMP HAS MORE THAN ONE MOTOR ERROR ALARM IN THE LAST THIRTY DAYS. 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 Known Impact Or Consequence To Patient
MAUDE report 6689306 ↗InjuryJun 29, 2017Failure to Deliver; Device Displays Incorrect Message
THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD A HIGH BLOOD GLUCOSE OF 600 MG/DL. THE CUSTOMER TREATED VIA MANUAL INSULIN INJECTION. PRIOR TO THE HIGH BLOOD GLUCOSE, THE INSULIN PUMP WOULD FAILED TO DELIVERY INSULIN DURING BOLUS ATTEMPTS. THE INSULIN PUMP HAD ALARMED WITH MULTIPLE MOTOR ERROR ALARMS. DURING TROUBLESHOOTING IT WAS CONFIRMED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. THE INSULIN PUMP WAS ABLE TO SUCCESSFULLY REWIND AS WELL. HOWEVER, THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO THEIR MEDICALLY PRESCRIBED BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 6678643 ↗InjuryJun 29, 2017Mechanical Problem; Failure to Deliver; High Test Results
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OF 400 MG/DL. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY AND MOTOR ERROR DURING BOLUS. THE CUSTOMER STATED THAT THE NO DELIVERY ALARM WAS RESOLVED BY CHANGING THE INFUSION SET AND RESERVOIR. THE CUSTOMER WAS ABLE TO REWIND THE INSULIN PUMP DURING TROUBLESHOOTING. THE DRIVE SUPPORT CAP APPEARED NORMAL. THE ALARM HISTORY SHOWED MORE THAN ONE MOTOR ERROR ALARM. IT WAS ADVISED TO DISCONTINUE THE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. THE RESERVOIR AND INFUSION SET WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 6677535 ↗MalfunctionJun 16, 2017Device Displays Incorrect Message; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED UNEXPECTED RESTART. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THERE WAS NO TEMP BASAL PROGRAMMED PRIOR TO THE UNEXPECTED RESTART ALARM. THE CUSTOMER REPORTED THAT INSULIN PUMP WAS NOT STORED OR NOT IN USED FOR AN EXTENDED PERIOD OF TIME. THE CUSTOMER ALSO STATED THE ALARM OCCURRED SHORTLY DURING BATTERY CHANGE. THE CUSTOMER WAS ADVISED TO REMOVE BATTERY AND INSERT NEW BATTERY. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED UNEXPECTED RESTART AGAIN. 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 6646673 ↗MalfunctionMay 31, 2017No Display/Image; Device Displays Incorrect Message
CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL BLANK DISPLAY ANOMALY AND LOW BATTERY ALARM ON THE INSULIN PUMP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 275 MG/DL. TROUBLESHOOTING FOR LOW BATTERY ALARM WAS PERFORMED. CUSTOMER¿S MOTHER REPLACED THE BATTERY. TROUBLESHOOTING FOR BLANK DISPLAY WAS PERFORMED. CUSTOMER REPLACED THE INSULIN PUMP WITH A NEW BATTERY THREE TIMES AS THE ISSUES REMAINED UNRESOLVED. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE AND THE DISPLAY DID NOT RETURN. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 6603483 ↗
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-1750-2026 · Feb 13, 2026 · Open, ClassifiedParadigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
- 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-1593-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723K
- Z-1590-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722K
- Z-1594-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723
- Z-1587-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522
- Z-1592-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523K
- Z-1589-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522K
- Z-1591-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523
- 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
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- 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
- 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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