PARADIGM® REAL-time MMT-522NAB (UDI 00613994312648)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994312648), received between Feb 1, 2018 and Nov 26, 2019 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Cycle” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2019Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ACT BUTTON WERE HARD TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED INSULIN PUMP HAD REJECT NEW BATTERIES, MOTOR WAS SLOWER TO REWIND, BACK LIGHT WAS DIMMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9374542 ↗
• MalfunctionJul 12, 2019Failure to Cycle; Patient Device Interaction Problem; Failure to Cycle; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 114 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER STATED THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED INSULIN PUMP WAS DROPPED AND THERE ARE CRACKS. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8784158 ↗
• MalfunctionMay 2, 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. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 130 MG/DL. TROUBLESHOOTING WAS PERFORMED FOR PRIME REWIND. CUSTOMER STATED INSULIN IS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. THE CUSTOMER INDICATED 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 8572919 ↗
• InjuryApr 5, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS 200 TO 250 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT ABLE TO REWIND. DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8486706 ↗
• InjuryJul 12, 2018Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD NO DELIVERY ALARM ON INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS HIGH OF 598 MG/DL. TROUBLESHOOTING DID NOT OCCUR AND TREATMENT METHODS WERE NOT MENTIONED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7683107 ↗
• MalfunctionFeb 1, 2018Break

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 190MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT SHE HAS HAD CHIPPING OFF HER RESERVOIR COMPARTMENT LID AND THEN ON THIS PAST SATURDAY THE GASKET CAME OUT BUT THE RESERVOIR WAS STAYING IN AND SHE WAS CURRENTLY USING THE PUMP. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7234372 ↗

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