Paradigm® REAL-Time Revel™ MMT-523NAP (UDI 00643169446410)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-523NAP PRDGM V2.5B PL US PR · Class 3
All models of Paradigm REAL-Time Revel (180)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Paradigm REAL-Time Revel insulin pump delivers insulin continuously for diabetes management. Reports mostly describe pumps giving error alarms or unexpected restarts, blank or unresponsive displays and buttons that are hard to press, and cracked reservoir compartments that let extra insulin leak out, alongside trouble programming or calibrating the device. There are 75 reports, with22 injuries and no deaths, mostly involving high or low blood sugar. 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
- 75
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00643169446410), received between Jun 6, 2017 and Aug 4, 2020 — classified as 22 injuries, 53 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (17 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
- Patient Device Interaction Problem17
- Device Displays Incorrect Message16
- Device Difficult to Program or Calibrate10
- Break9
- Adverse Event Without Identified Device or Use Problem7
- Mechanical Problem6
- No Apparent Adverse Event5
- Crack4
Patient problems
- No Consequences Or Impact To Patient44
- Hyperglycemia24
- Hypoglycemia9
- Elevated Ketones/ Diabetic Ketoacidosis2
- Abdominal Pain1
- Dyspnea1
- Nausea1
- No Code Available1
Recent adverse event reports
The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2020Premature Discharge of Battery; Premature Discharge of Battery
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ERROR ALARM. 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 10360603 ↗MalfunctionMar 13, 2020Premature Discharge of Battery; Loss of Data; Premature Discharge of Battery; Loss of Data
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RECEIVED MULTIPLE PUMP ERROR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT SHE WAS JUST CHANGING THE BATTERY WHEN SHE RECEIVED THE ALERTS FOR THE FIRST TIME. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER NOT ABLE TO COMPLETE REWIND. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9827791 ↗InjuryMar 5, 2020No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem
CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL 34 MG/DL. CUSTOMER STATED THAT THE RESERVOIR COMPARTMENT WAS CRACKED AND LOT'S OF INSULIN WAS DELIVERED. CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK INTO PLACE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 9791409 ↗MalfunctionJan 29, 2020No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY AND BUTTONS WERE REALLY HARD TO PRESS. CUSTOMER STATED THE BATTERY WAS CHANGED MULTIPLE TIMES, BUT THE ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9640513 ↗MalfunctionDec 18, 2019Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD ESC BUTTON WERE HARD TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT INSULIN PUMP HAD REJECTS NEW BATTERIES, NO DELIVERY ALARM AND THEN WILL NOT DELIVER INSULIN, BATTERY AREA WAS SCRATCHED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9488269 ↗MalfunctionNov 22, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL 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 9362469 ↗MalfunctionNov 14, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SEVERAL ISSUES. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A NO DELIVERY ALARM AND THE BUTTONS WERE UNRESPONSIVE. CUSTOMER DECLINED TROUBLESHOOTING. INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9320264 ↗MalfunctionNov 11, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem
THE CUSTOMER'S FAMILY REPORTED VIA PHONE THAT THE ESC BUTTON WAS HARD TO PRESS. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9304063 ↗InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 535 MG/DL AND LOW BLOOD GLUCOSE OF 25 MG/DL. CUSTOMER ALSO HAD BLOOD GLUCOSE OF 100 MG/DL AND 370 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR BLOOD GLUCOSE ISSUE. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 9295386 ↗InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 535 MG/DL, 25 MG/DL. CUSTOMER STATED OTHER BLOOD GLUCOSE VALUE WAS 100 MG/DL, 370 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 9294408 ↗MalfunctionNov 6, 2019Failure to Cycle; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Failure to Cycle; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 119 MG/DL. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. CUSTOMER TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9283422 ↗MalfunctionOct 2, 2019Failure to Cycle; Failure to Cycle
THE CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED BROKEN FORCE SENSOR ALARM. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 326 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONTINUED THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. CUSTOMER TREATED WITH MANUAL INJECTION. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL.
Patient problems: Hyperglycemia
MAUDE report 9143951 ↗MalfunctionSep 10, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD TO PRESS BUTTONS MORE THAN ONCE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE BATTERY CAP WAS HARD TO SCREW ON BATTERY AND BATTERY CAP WAS STRIPPED AND ALSO HAD CRACK. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8982444 ↗MalfunctionAug 27, 2019Failure to Cycle; Failure to Cycle
THE CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 223 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND ALSO THEY WERE ABLE TO REWIND INSULIN PUMP. CUSTOMER WAS PERFORMED SELF TEST AND IT WAS PASSED. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8935519 ↗MalfunctionJul 23, 2019Mechanical Problem; Priming Problem; Mechanical Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE THEY CAN'T COMPLETE THE REWIND PROCESS. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER STATED THAT NUMBERS APPEARED ON THE SCREEN. THE CUSTOMER WAS ADVICE THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVICE TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8814723 ↗MalfunctionJul 22, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE HARDER TO PRESS OF INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER WAS ALSO REPORTED THAT INSULIN PUMP HAD REJECTED NEW BATTERIES, RANDOM AND UNEXPLAINED NO DELIVERY ALARMS, MOTOR WAS GRINDING, LOST DATA AND SETTINGS, BATTERY LASTS 6 DAYS TO 1.5 WEEK. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8810348 ↗InjuryJul 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER'S NURSE REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS ON JULY 1 WITH BLOOD GLUCOSE OF 500 MG/DL. THE CUSTOMER EXPERIENCED THE SYMPTOMS RELATED TO THE HIGH BLOOD GLUCOSE WAS NAUSEA, VOMITING, ABDOMINAL PAIN, DIFFICULTY IN BREATHING. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. THE PATIENT TROUBLESHOOTING WAS PERFORMED FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. THE CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Abdominal Pain; Dyspnea; Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Nausea; Vomiting
MAUDE report 8774888 ↗MalfunctionJun 13, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THEIR DAUGHTER'S INSULIN PUMP WAS BROKEN. THE CUSTOMER FELL AND LANDED ON THE DEVICE. THE BOTTOM OF THE INSULIN PUMP CAME OFF AS WELL AS THE WIRES AND THE BATTERY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8698497 ↗MalfunctionJun 11, 2019Device Difficult to Program or Calibrate; Date/Time-Related Software Problem; Device Difficult to Program or Calibrate; Date/Time-Related Software Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE NOT RESPONDING. CUSTOMER¿S BLOOD GLUCOSE WAS 210 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE TIME WAS NOT ADVANCING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8685859 ↗MalfunctionFeb 1, 2019Power Problem; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED A REPLACE BATTERY ALERT WITHOUT A LOW BATTERY ALERT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THE TYPE OF BATTERY IN USE WAS AAA (B)(6). THE CUSTOMER STATED THAT THE BATTERY WAS NOT PREVIOUSLY USED. CUSTOMER STATED THE BATTERY CAP WAS NOT LOOSE, CRACKED OR DAMAGED. THE CUSTOMER STATED THAT THIS WAS THE SECOND OCCURRENCE OF REPLACE BATTERY ALERT WITHOUT A LOW BATTERY WARNING. THE CUSTOMER ALSO REPORTED REPEATED FAILED BATTERY ALERTS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8296011 ↗MalfunctionJan 25, 2019Device Alarm System; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Alarm System; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DAMAGED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD SOME DISCOLORATION ON THE SCREEN, REWIND TOOK LONGER. BUTTONS WERE HARDER TO PUSH, ALARM WAS NOT AS LOUD AT ALL, SCREEN LOST SOME BRIGHTNESS AND CRACK ON PUMP BY THE RESERVOIR COMPARTMENT. CUSTOMER DECLINED TROUBLESHOOTING FOR ISSUES REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8277258 ↗InjuryJan 9, 2019Material Integrity Problem; No Apparent Adverse Event; Patient Device Interaction Problem; Material Integrity Problem; No Apparent Adverse Event; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE WAS SOMETHING IN A RANGE OF 200 TO 400 MG/DL. CUSTOMER¿S OTHER BLOOD GLUCOSE LEVEL WAS 300 MG/DL. CUSTOMER TREATED WITH INSULIN SHOT. CUSTOMER STATES THEY ARE UNABLE TO REMOVE THE BATTERY CAP ON THEIR INSULIN PUMP. CUSTOMER UNABLE TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. CUSTOMER STATES INSULIN PUMP WAS DIED BECAUSE CANNOT REMOVE THE BATTERY CAP TO CHANGE THE BATTERY. 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: Hyperglycemia
MAUDE report 8230622 ↗MalfunctionDec 27, 2018Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE BUTTONS WERE HARD TO PRESS AND INSULIN PUMP WAS LESS RESPONSIVE AND ALSO HAD SCRATCHES ON THE SCREEN AND NUMBER WERE BLURRY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8200184 ↗MalfunctionDec 11, 2018Patient Device Interaction Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD DAMAGE IN RESERVOIR COMPARTMENT. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER REPORTS THAT CLEAR LIP POPS OFF CONCERNED ABOUT LOSING SECURITY. RESERVOIR WAS NOT ABLE TO LOCKED IN PLACE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8149837 ↗InjuryNov 28, 2018No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA ON END OF JANUARY WITH BLOOD GLUCOSE LEVEL WAS 500 MG/DL, 423 MG/DL AT TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE LEVEL WAS 161 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH INSULIN PUMP AND MANUAL INJECTION. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER STATED THAT THE SYMPTOMS RELATED TO HIGH BLOOD GLUCOSE SUCH AS NAUSEA. CUSTOMER ALLEGES THAT THE INSULIN PUMP WAS UNDER DELIVERING BECAUSE THERE HAS BEEN CRACKED ON THE INSULIN PUMP. CUSTOMER STATES THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER STATED INSULIN EXITED AT THE QUICK RELEASE. CUSTOMER STATED THAT THE INSULIN PUMP WAS DROPPED FEW TIMES AND HAD CRACK STARTING ON RIGHT CORNER OF THE SCREEN UP TO THE CASE ABOUT THREE QUARTER OF AN INCH AND ALSO CRACK ON THE SCREEN OF THE RESERVOIR COMPARTMENT. CUSTOMER STATED THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8109801 ↗
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-1590-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722K
- 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-1594-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723
- Z-1593-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723K
- Z-1591-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523
- Z-1587-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522
- 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
- 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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