Paradigm® REAL-Time Revel™ MMT-723RNAL (UDI 00613994748737)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00613994748737), received between Jun 5, 2017 and Feb 13, 2019 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2019Premature Discharge of Battery; Power Problem; Unexpected Shutdown; Premature Discharge of Battery; Power Problem; Unexpected Shutdown

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PUMP ERROR SIGNAL TOO LOW ALARM AND NO DELIVERY/OCCLUSION ALARM DURING THERAPY. CUSTOMER BLOOD GLUCOSE LEVEL WAS 200 MG/DL. CUSTOMER ALSO STATED THAT THE THEY WERE ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8338111 ↗
• MalfunctionOct 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR AND DRIVE SUPPORT CAP ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED A MOTOR ERROR ALARM DURING BOLUS. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND WAS ADVISED TO REFER TO BACK UP PLAN, PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7950850 ↗
• MalfunctionMay 16, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR DURING BOLUS DELIVERY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. 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: No Consequences Or Impact To Patient

  MAUDE report 7520754 ↗
• MalfunctionMay 3, 2018Device Operates Differently Than Expected

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD UNEXPECTED RESTART WHEN CHANGES THE BATTERY. CUSTOMER STATED THAT THEY PERFORMED TROUBLESHOOT BUT INSULIN PUMP AGAIN EXPERIENCED MULTIPLE UNEXPECTED RESTART ALARMS AFTER BATTERY CHANGE. CUSTOMER'S CURRENT BLOOD GLUCOSE WAS NOT GIVEN. INSULIN PUMP WILL NOT BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7482793 ↗
• MalfunctionApr 25, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 220 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT DURING SEATING THE FORCE SENSOR DID NOT DETECT THE RESERVOIR. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. 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 NOT RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7458892 ↗
• MalfunctionOct 12, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED A COMPROMISED FORCE SENSOR SYSTEM ALARM DURING THE FILL TUBING PROCESS. CUSTOMER'S BLOOD GLUCOSE WAS 131 MG/DL. TROUBLESHOOTING FOUND THE CUSTOMER'S DRIVE SUPPORT CAP WAS FLUSH. CUSTOMER COULD NOT RECALL PRESSING ON THE CAP WHILE CONNECTED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED. CUSTOMER AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6946913 ↗
• InjurySep 14, 2017Failure to Prime; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP WOULD NOT EXIT THE PREPARING TO PRIME SCREEN AND ALARMED COMPROMISED FORCE SENSOR SYSTEM ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 600 MG/D AT THE TIME OF THE INCIDENT. CUSTOMER TREATED WITH MANUAL INJECTION FOR THE HIGH BLOOD GLUCOSE LEVEL. CUSTOMER STATES THAT THEY HAVE DROPPED THE INSULIN PUMP BEFORE GETTING THE ALARMS. 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: Hyperglycemia

  MAUDE report 6864943 ↗
• MalfunctionAug 21, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED A MOTOR ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 196 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6808476 ↗
• MalfunctionJul 10, 2017Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED TO HOLD DOWN THE ACT BUTTON UNTIL THEY RECEIVE A SERIES OF BEEPS AND THE NUMBERS APPEAR ON THE DISPLAY. THE CUSTOMER STATED THE INSULIN PUMP BEEPED BUT THE NUMBERS DID NOT APPEAR. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6699065 ↗
• MalfunctionJun 28, 2017Loose or Intermittent Connection; Failure to Sense; Device Displays Incorrect Message

  CUSTOMER REPORTED VIA PHONE CALL THAT THERE WAS A COMPROMISED FORCE SENSOR SYSTEM ALARM ON THE INSULIN PUMP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING FOR THE PRIME REWIND WAS PERFORMED. CUSTOMER ADVISED DURING THE MANUAL PRIME PROCESS THE ALARM OCCURRED. CUSTOMER ADVISED THE DRIVE SUPPORT CAP WAS LOOSE. CUSTOMER ADVISED DURING THE SEATING OF THE FORCE THE SENSOR DID NOT DETECT THE RESERVOIR. 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 6675459 ↗
• InjuryJun 20, 2017Retraction Problem

  THE CUSTOMER'S WIFE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NOT REWINDING. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 538 MG/DL. DURING TROUBLESHOOTING, THE CUSTOMER WAS ADVISED THAT A FEATURE THAT PREVENTED THE DEVICE FROM REWINDING WAS ACTIVATED. THE INSULIN PUMP WAS NOT REPLACED OR RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6655181 ↗
• MalfunctionJun 20, 2017Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. 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 6654192 ↗
• InjuryJun 6, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 474 MG/DL, WHICH WAS TREATED WITH MANUAL INJECTION. CUSTOMER ALSO REPORTED A BLOOD GLUCOSE LEVEL OF 457 MG/DL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS 182 MG/DL. TROUBLESHOOTING WAS NOT COMPLETED; THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

  Patient problems: Hyperglycemia; No Consequences Or Impact To Patient

  MAUDE report 6615814 ↗
• MalfunctionJun 5, 2017Device Displays Incorrect Message; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM THE CUSTOMER INDICATED THE DRIVE SUPPORT CAP WAS PROTRUDED. THE CUSTOMER DID NOT PROVIDE THEIR BLOOD GLUCOSE VALUE AT THE TIME OF THE INCIDENT STYLE 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 WILL NOT BE RETURNING THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6612756 ↗

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