Paradigm® REAL-Time Revel™ MMT-523LNAB (UDI 00643169513822)Recalls & reported problems

Summary

The FDA's MAUDE database contains 592 adverse event reports that list this exact device (DI 00643169513822), received between May 16, 2017 and Jan 10, 2024 — classified as 5 deaths, 270 injuries, 317 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (85 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

Recent adverse event reports

The 25 most recent of 592 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2024Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED A MOTOR ERROR DURING THE REWIND. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND THE PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 18481889 ↗
• MalfunctionSep 25, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT RESERVOIR COMPARTMENT WAS BROKEN OFF IN PIECES OF THE INSULIN PUMP. CUSTOMER ALSO STATED THAT INSULIN PUMP HAD CRACK ON THE RETAINER RING AND RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. 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 10584672 ↗
• MalfunctionAug 7, 2020Mechanical Problem; Battery Problem; Power Problem; Priming Problem; Mechanical Problem; Battery Problem; Power Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. INSULIN PUMP HAD NO DELIVERY ALARM. INSULIN PUMP REJECTED NEW BATTERIES. INSULIN WAS SQUIRTING OUT DURING PRIME. 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 10377790 ↗
• InjuryAug 6, 2020Excess Flow or Over-Infusion; No Apparent Adverse Event; Excess Flow or Over-Infusion; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2020 WITH BLOOD GLUCOSE 407 MG/DL, 72 MG/DL AND 30 MG/DL. THE CUSTOMER WAS TREATED WITH INTRAVENOUS INSULIN DRIP FOR HIGH BLOOD GLUCOSE. CUSTOMER WAS EXPERIENCED LOW BLOOD GLUCOSE. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER WAS IN EMERGENCY ROOM. THE CUSTOMER STATED THAT THEY DID ALLEGE INSULIN PUMP WAS OVER DELIVERING. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL BE AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10371675 ↗
• MalfunctionJul 31, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THEY GOT THE ALARM AFTER INSULIN SHOOTS OUT. DRIVE SUPPORT CAP IS NOT NORMAL. 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 10349133 ↗
• MalfunctionJul 28, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP KEYS WERE HESITATING TO RESPOND WHILE GOING TO SET A BOLUS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10331244 ↗
• MalfunctionJul 8, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 10243593 ↗
• MalfunctionJun 26, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM 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 10199598 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 478 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED SHE PUT NEW INFUSION SET INTO HER BODY AND NEEDLE BROKE OFF INSIDE THE BODY. THE SITE WAS HURT, SHE CHANGED THE SITE OF INSERTION. THE CUSTOMER¿S BLOOD GLUCOSE WENT HIGH BECAUSE THE NEEDLE BLOCKED THE INSULIN FROM GETTING INTO HER BODY. THE CUSTOMER¿S BOYFRIEND SURGICALLY REMOVE NEEDLE FROM HER SKIN. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH BOLUS. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Discomfort; Foreign Body In Patient; Hyperglycemia; Pain

  MAUDE report 10193838 ↗
• MalfunctionJun 24, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT HALF OF THE RESERVOIR COMPARTMENT ENTRANCE BROKE OFF. CUSTOMER REPORTED THAT THERE WAS PHYSICAL DAMAGE TO THE INSULIN PUMP'S RETAINER RING AND THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10188343 ↗
• MalfunctionJun 3, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S ACT AND ARROW BUTTONS WERE UNRESPONSIVE. CUSTOMER STATED THAT THAT INSULIN PUMP HAD CRACK ON THE FRONT SIDE OF THE INSULIN PUMP NEAR UP AND DOWN SIDE. THE INSULIN PUMP HAD MOTOR ERRORS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10113462 ↗
• MalfunctionJun 2, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE O RING WAS CRACK AND MISSING. TROUBLESHOOTING WAS DONE FOR COSMETIC DAMAGE. THE RESERVOIR WAS UNABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. 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 10107934 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA CALL THAT THE THEY WENT TO EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE LEVEL ON (B)(6) 2020. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 300 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP AND MANUAL INJECTION. CUSTOMER DID NOT ALLEGE INSULIN PUMP FOR UNDER DELIVERY. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED THAT THERE WAS AIR BUBBLES IN THE TUBING. APPROXIMATE SIZE OF AIR BUBBLES IS LARGE AIR BUBBLE ABOUT AN INCH FROM THE PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10104783 ↗
• MalfunctionMay 26, 2020Mechanical Problem; Environmental Compatibility Problem; Mechanical Problem; Environmental Compatibility Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER REPORTED THAT THEY WERE NOT ABLE TO CLEAR THE MOTOR ERROR ALARM. CUSTOMER REPORTED THAT THEY REWOUND THE INSULIN PUMP. INSULIN PUMP WAS EXPOSED TO HIGH MAGNETIC FIELD THAT WAS MAGNETIC RESONANCE INDEX. 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 10086908 ↗
• MalfunctionMay 11, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT RESERVOIR PLASTIC WAS BRAKING, O-RING WAS COMING OUT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT RESERVOIR ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10042132 ↗
• MalfunctionApr 30, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED AND STOPPED INSULIN DELIVERY AND THERE IS NO INDICATION THAT THE ALARM IS RESOLVED. NO TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10012749 ↗
• MalfunctionApr 29, 2020Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE WAS CHIPPED ON THE RESERVOIR WHEN REMOVING. CUSTOMER STATED THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARM AND REJECTED THE BATTERY. TROUBLESHOOTING WAS DECLINED. 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 10012279 ↗
• MalfunctionApr 28, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER STATED THAT THE RESERVOIR RETAINER RING WAS BROKEN OFF AND INSULIN PUMP MADE LOUD BUZZING NOISE DURING BOLUS. IT WAS REPORTED THAT THE ACTIVATE BUTTON WAS HARDER TO PRESS. 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 10003901 ↗
• MalfunctionApr 15, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP BUTTON WAS NOT RESPONSIVE. CUSTOMER CANNOT RECALL BLOOD GLUCOSE AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS NOT PERFORMED. CUSTOMER ALSO REPORTED BATTERY ISSUE AND PHYSICAL DAMAGE. THE INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9965101 ↗
• InjuryApr 14, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OF 411 MG/DL. CUSTOMER¿S OTHER BLOOD GLUCOSE WAS 417 MG/DL,245 MG/DL. THE CUSTOMER TREATED WITH THE INSULIN PUMP AND MANUAL INJECTION. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER WAS PERFORMING HIGH PRESSURE TEST AND RECEIVED NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9959823 ↗
• InjuryApr 14, 2020Adverse 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 THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. THE BLOOD GLUCOSE OF CUSTOMER WAS 35 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE LEVEL EVENT. CUSTOMER WAS NEITHER IN EMERGENCY ROOM NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICES DISPATCHED AS A RESULT OF LOW BLOOD GLUCOSE. CUSTOMER WAS ALLEGING INSULIN PUMP WAS OVER DELIVERING. THE CUSTOMER WAS TREATED WITH FOOD. THE CUSTOMER DID NOT EXPERIENCED ANY OTHER SYMPTOMS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9956454 ↗
• MalfunctionApr 8, 2020No Display/Image; Communication or Transmission Problem; Power Problem; No Display/Image; Communication or Transmission Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP DISPLAY WAS BLANK. CUSTOMER DID NOT MENTION BLOOD GLUCOSE AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS PERFORMED. CUSTOMER MENTIONED FAILED BATTERY TEST AND WEAK SIGNAL ALARM ALSO. CUSTOMER DID NOT MENTION THE CAUSE OF THE BLANK DISPLAY. THE CUSTOMER INSERTED NEW BATTERY BUT THE ISSUE REOCCURRED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9935934 ↗
• MalfunctionApr 3, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR COMPARTMENT CRACKED AND CHIPPED OFF. CUSTOMER STATED RESERVOIR WAS UNABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. 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 9920801 ↗
• MalfunctionApr 1, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ACT BUTTON OF THE INSULIN PUMP DID NOT RESPOND WHEN SHE PUSHES ON IT. CUSTOMER STATED THAT SHE HAD TO FIND A CERTAIN SPOT TO PUSH ON AND GOT THE ACT BUTTON TO WORK. 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 9909552 ↗
• MalfunctionMar 27, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BUTTONS ARE HARD TO PRESS OR NON RESPONSIVE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9892061 ↗

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, Classified
  Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
• Z-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• Z-1256-2025 · Jan 31, 2025 · Open, Classified
  Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-2442-2015 · Jul 22, 2015 · Terminated
  Guardian 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 · Terminated
  Medtronic 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 · Terminated
  Medtronic 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