Paradigm® REAL-Time Revel™ MMT-523RNAH (UDI 00643169476479)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169476479), received between Nov 16, 2017 and Dec 2, 2019 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SLOWER REWIND, RANDOM NO DELIVERY AS WELL AS KEYPAD BUTTONS WAS UNRESPONSIVE. CUSTOMER DECLINE TO TROUBLESHOOTING. CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9394228 ↗
• MalfunctionSep 27, 2019Device Difficult to Program or Calibrate; Battery Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Battery Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS HAD TO BE PRESSED MORE THAN ONCE, ALSO LOST THE SETTINGS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED INSULIN PUMP HAD CRACK ON THE TOP, BATTERY LAST 7 DAYS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9127536 ↗
• MalfunctionAug 12, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COSMETIC DAMAGE AND CRACK AROUND BATTERY COMPARTMENT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT RESERVOIR WAS NOT ABLE 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 8882802 ↗
• InjuryNov 22, 2018Insufficient Flow or Under Infusion; Patient Device Interaction Problem; Insufficient Flow or Under Infusion; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL AT THE TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE LEVEL WAS 429 MG/DL. THE CUSTOMER¿S OTHER BLOOD GLUCOSE LEVEL WAS 367 MG/DL AT THE TIME OF CALL. THE CUSTOMER DID NOT PROVIDE DETAILS ON SYMPTOMS RELATED TO THE HIGH BLOOD GLUCOSE LEVEL EPISODES. CUSTOMER WAS TREATED WITH THE MANUAL INJECTION. CUSTOMER ALLEGES INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER ALSO REPORTED THAT THE LIP RING FROM RESERVOIR WAS CRACK AROUND THE TOP. CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. CUSTOMER WAS NOT CALLING BACK TO PERFORMED HIGH PRESSURE TEST. CUSTOMER DECLINED TO CHECK FOR THE PRESENCE OF LEAKS OR AIR BUBBLES IN THE TUBING OR RESERVOIR. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8098172 ↗
• MalfunctionSep 17, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE INSULIN PUMP HAD RING ON RESERVOIR COMPARTMENT WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 243 MG/DL AT THE TIME OF THE INCIDENT. DRIVE SUPPORT CAP WAS LOOSE. ADVISE TO CUSTOMER THE PUMP WILL NEED TO BE REPLACED AND REVERT THE BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7880178 ↗
• InjuryAug 23, 2018Adverse 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 600 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7811394 ↗
• MalfunctionAug 22, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE INSULIN PUMP HAD DAMAGE. BLOOD GLUCOSE VALUE WAS 600+MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS NOT HOSPITALIZED. TROUBLESHOOTING WAS PERFORMED AND THE DEVICE WILL BE REPLACED AND RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7807742 ↗
• InjuryJul 9, 2018Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THEY TREATED HIGH BLOOD GLUCOSE WITH BOLUS FROM THE INSULIN PUMP. THE CUSTOMER WAS ABLE TO REWIND THE INSULIN PUMP. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7672384 ↗
• MalfunctionApr 13, 2018Break; Crack

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THERE WAS CRACK ON THE AT THE UPPER RIGHT SCREEN AREA AND RESERVOIR LIP WAS CRACKED AND FIXED TO BREAK OFF. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7428131 ↗
• MalfunctionNov 16, 2017Loose or Intermittent Connection; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER HAD TROUBLE WITH THE INSULIN PUMP; THE RESERVOIR WAS MISSING AN O-RING. THE CUSTOMER STATED THAT THEY PLACED A RUBBER BAND ON THE RESERVOIR. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER STATED THAT THE BATTERY CAP WAS LOOSE AND THERE WAS A MISSING O-RING IN THE RESERVOIR. THE CUSTOMER'S BLOOD GLUCOSE WAS 136 MG/DL AT THE TIME OF THE PHONE CALL. THE CUSTOMER STATED THAT THE DAMAGE OCCURRED WHEN THE INSULIN PUMP FELL OUT OF HER BRA. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN PER PHYSICIAN'S INSTRUCTION AND THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7039443 ↗

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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• 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