Paradigm® REAL-Time Revel™ MMT-723RNAP (UDI 00613994904393)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-723RNAP PRDGM INS V2.4 PL EN RC · 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 and tracks glucose. The 37 reports mostly describe pumps showing error messages, buttons that need repeated presses, cracked or broken parts, and sensors that are hard to program or seat. Reports also mention blood sugar running high (15 cases) and low (10 cases), with 23 injuries and 1 death. No recalls name this device, and no reports were filed in the past 12 months.
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
- 37
- Deaths reported
- 1
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00613994904393), received between Jun 13, 2017 and Nov 20, 2019 — classified as 1 death, 23 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (9 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 Message9
- Adverse Event Without Identified Device or Use Problem8
- Break4
- Crack2
- Device Difficult to Program or Calibrate2
- Excess Flow or Over-Infusion2
- Failure to Cycle2
- Mechanical Problem2
Patient problems
- Hyperglycemia15
- No Consequences Or Impact To Patient11
- Hypoglycemia10
- Elevated Ketones/ Diabetic Ketoacidosis2
- Death1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE THAT INSULIN PUMP BUTTON WAS UNRESPONSIVE AND HAD TO PRESS MORE THAN ONCE. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9347442 ↗InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
THE CUSTOMERS FAMILY MEMBER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE LEVEL WAS ABOVE 600 MG/DL. THE CUSTOMER WAS OFFERED FOR TROUBLESHOOTING AND DECLINED. THE CUSTOMER WAS TREATED WITH INSULIN DRIP FOR HIGH BLOOD GLUCOSE. CUSTOMER EXPERIENCED SYMPTOMS SUCH AS PAIN IN ARMS AND CHEST. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia; Pain
MAUDE report 9097434 ↗MalfunctionJul 26, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS OF INSULIN PUMP WAS NOT AS RESPONSIVE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8830397 ↗InjuryMay 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OF 529MG/DL. CUSTOMER WAS TREATED WITH BOLUS. CUSTOMER DOES NOT ALLEGED FOR UNDER DELIVERY AND DRIVE SUPPORT CAP WAS NORMAL. INSULIN PUMP WILL BE RETURN FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8614402 ↗MalfunctionApr 26, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM DURING SEATING THE FORCE SENSOR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 261 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS 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 INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8553611 ↗MalfunctionApr 15, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP SCREEN WAS CLOUDY AND MAKING DIFFICULT TO READ. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8513371 ↗DeathFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME. THE CAUSE OF DEATH WAS DIABETES AND ACUTE CORONARY SYNDROME. THE CALLER STATED THAT THE CUSTOMER HAD DIABETES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER WAS UNSURE IF THE CUSTOMER WAS USING SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS AS THE POLICE AND FUNERAL HOME DID NOT RETURN IT TO THEM.
Patient problems: Death
MAUDE report 8305458 ↗MalfunctionDec 3, 2018Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. 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 8123636 ↗InjuryNov 5, 2018Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A HIGH BLOOD GLUCOSE LEVEL OF 439 MG/DL. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP RECEIVED INSULIN FLOW BLOCKED ALARM. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN EXITED AT QUICK RELEASE. THE CUSTOMER DECLINED THE TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE AND THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8037926 ↗InjuryOct 26, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE IN THE EMERGENCY ROOM ON (B)(6) 2018 WITH A BLOOD GLUCOSE RANGING FROM 20 MG/DL TO 50 MG/DL. THE CUSTOMER WAS AT 83 M/DL AT THE TIME OF ADMISSION AND 264 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER USED JUICE AND WAS GIVEN GLUCOSE TABLETS TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE PUMP WAS ALLEGEDLY OVER DELIVERING INSULIN. TROUBLESHOOTING WAS NOT COMPLETED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 8009687 ↗MalfunctionOct 25, 2018Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP REJECTED NEW BATTERIES 3 TIMES IN ONE WEEK. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER DECLINED FOR TROUBLESHOOTING. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP MADE GRINDING NOISE DURING REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8005332 ↗InjuryOct 19, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 20 TO 50 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 83 M/DL AT THE TIME OF ADMISSION, AND 264 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER USED JUICE AND WAS GIVEN GLUCOSE TABLETS TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE PUMP WAS ALLEGEDLY OVER DELIVERING INSULIN. TROUBLESHOOTING WAS NOT COMPLETED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 7983039 ↗InjuryOct 9, 2018Failure to Cycle; Failure to Cycle
IT WAS REPORTED THAT THE CUSTOMER RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE WITH BLOOD GLUCOSE OF 20 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS GIVEN A GLUCAGON SHOT TO TREAT. THE CALLER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER RECEIVED A COMPROMISED FORCE SENSOR SYSTEM ALARM. TROUBLESHOOTING WAS NOT COMPLETED BUT THE PUMP WAS ABLE TO REWIND. NO FURTHER INFORMATION WAS PROVIDED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 7948654 ↗InjurySep 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2017 WITH BLOOD GLUCOSE OF 508 MG/DL AND THE CURRENT BLOOD GLUCOSE OF THE PATIENT WAS 201 MG/DL. CUSTOMER STATED THAT THE OTHER BLOOD GLUCOSE VALUE WAS 390 MG/DL, 345 MG/DL, 397MG/DL, 400 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN VIA SYRINGE AND FLUIDS. CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. CUSTOMER STATED THE DRIVE SUPPORT CAP APPEARS NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7880196 ↗InjuryJul 13, 2018Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE INSULIN PUMP HAD A LOW BLOOD GLUCOSE VALUE OF 38 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER TREATED WITH A GLUCOSE TABLET. THE CUSTOMER ALSO STATED THE INSULIN PUMP HAD PHYSICAL DAMAGE. NO TROUBLESHOOTING WAS PERFORMED FOR THE LOW BLOOD GLUCOSE VALUE. TROUBLESHOOTING FOR DAMAGE RESULTED IN THE INSULIN PUMP BEING REPLACED AND RETURNED.
Patient problems: Hypoglycemia
MAUDE report 7688139 ↗InjuryJun 21, 2018Break
CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 19 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS BABY SITTING AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS GIVEN INTRAVENOUS FLUIDS TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS FOAMING AT THE MOUTH. IT IS UNKNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AND NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER HAD FOUR OTHER LOW EVENTS AND REPORTED PUMP PHYSICAL DAMAGE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 7624131 ↗InjuryJun 21, 2018Physical Property Issue
CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 32 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS DOING YARD WORK AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS GIVEN FOOD AND GLUCOSE GEL TO TREAT. IT IS UNKNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AND NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED PUMP PHYSICAL DAMAGE AND 4 OTHER LOW EVENTS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 7624130 ↗InjuryJun 21, 2018Break
CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 34 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS SWEATING PROFUSELY AND BELLIGERENCE. IT IS UNKNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AND NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER HAD FOUR OTHER LOW EVENTS AND REPORTED PUMP PHYSICAL DAMAGE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 7624106 ↗InjuryJun 21, 2018Break
CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 36 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS DRIVING AND COULD NOT GET THEIR FOOT OFF THE ACCELERATOR PEDAL AND A TEACHER ASSISTED THEM PUT BRAKES ON THE CAR. THE CUSTOMER WAS GIVEN SODA AND INTRAVENOUS FLUIDS TO TREAT. IT IS UNKNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED. THE CUSTOMER REPORTED PUMP PHYSICAL DAMAGE. THE CUSTOMER ALSO HAD FOUR OTHER LOW INCIDENTS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 7624105 ↗InjuryMay 9, 2018Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCED SENSOR SYSTEM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 323 MG/DL. THE CUSTOMER WAS ASSISTED WITH THE TROUBLESHOOTING. THE CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS AND THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. THE INSULIN PUMP WILL BE RETURNED FOR THE ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7497603 ↗InjuryFeb 16, 2018Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 308 MG/DL AT THE TIME OF THE INCIDENT AND TREATED WITH MANUAL INJECTION. CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR AFTER POSSIBLE EXPOSURE TO MRI. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THAT THE INSULIN PUMP COULD HAVE BEEN EXPOSED TO HIGH MAGNETIC FIELDS. CUSTOMER REPORTED A MOTOR POSITION ENCODER ERROR. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7276720 ↗MalfunctionFeb 2, 2018Crack; Device Displays Incorrect Message
THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE CUSTOMER RECEIVED WITH MULTIPLE INSULIN PUMP ERRORS. THE BLOOD GLUCOSE WAS 243 MG/DL AT THE TIME OF THE INCIDENT. ALARM DID NOT OCCUR DURING THE REWIND AND PRIME SEQUENCE. ASSISTED CUSTOMER IN PERFORMING A SELF TEST WHICH WAS FAILED. ERROR TABLE INDICATES THE PUMP SHOULD BE REPLACED. THE INSULIN PUMP WAS CRACKED. TROUBLESHOOTING DETERMINED THAT, THE INSULIN PUMP SHOULD BE REPLACED AND REVERT TO A BACK-UP PLAN. THE INSULIN DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7239515 ↗MalfunctionFeb 2, 2018Device 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 UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS 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 INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7236314 ↗MalfunctionJan 31, 2018Crack
THE CUSTOMER REPORTED VIA PHONE CALL THAT THERE WAS CRACK AROUND THE RIM AND ON LCD SCREEN . THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 127 MG/DL. THE CUSTOMER ALSO REPORTED THAT THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7232741 ↗InjuryOct 24, 2017Device Displays Incorrect Message
THE CUSTOMER¿S SPOUSE REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS IN THE 400 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER¿S SPOUSE STATED THAT THE INSULIN PUMP. THE CUSTOMER¿S PARENT STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. CUSTOMER REPORTED TO HAVE RECEIVED A MOTOR POSITION ENCODER ERROR. CUSTOMER'S SPOUSE ALSO REPORTED CUSTOMER HAD EXPERIENCED A HIGH BLOOD GLUCOSE OF OVER 400 MG/DL AND TREATED WITH MANUAL INJECTION. DECLINED HIGH BLOOD GLUCOSE TROUBLESHOOTING. THE CUSTOMER¿S PARENT WAS ADVISED TO HAVE CUSTOMER DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 6972330 ↗
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-1750-2026 · Feb 13, 2026 · Open, ClassifiedParadigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
- Z-1256-2025 · Jan 31, 2025 · Open, ClassifiedParadigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
- 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-1588-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722
- 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-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-1590-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722K
- 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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