PARADIGM® REAL-time MMT-522NAL (UDI 00613994312624)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994312624), received between Aug 10, 2017 and Feb 20, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM AND 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 9736291 ↗
• MalfunctionSep 11, 2019Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART AND KEYPAD ANOMALY. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED THEY WERE UNABLE TO CLEAR THE ALARM. CUSTOMER REPORTED THAT THE TIME CLOCK WAS ADVANCED. 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 AS PER HEALTHCARE PROFESSIONAL INSTRUCTION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8988852 ↗
• MalfunctionNov 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING OUT DURING MANUAL PRIME PROCESS. CUSTOMER ADVISED THE DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER ADVISED DURING THE SEATING OF THE FORCE THE SENSOR DID NOT DETECT THE RESERVOIR. 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 Known Impact Or Consequence To Patient

  MAUDE report 8071266 ↗
• InjuryJul 20, 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 OVER 400 MG/DL AND AFTER FEW HOURS IT WAS 425 MG/DL. THE CUSTOMER WAS TREATED BY THE INSULIN PUMP. THE CUSTOMER DECLINED TO TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7705704 ↗
• MalfunctionAug 10, 2017Loose or Intermittent Connection; Device Displays Incorrect Message; Device Sensing Problem

  CUSTOMER REPORTED VIA PHONE CALL 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 THEY WERE UNABLE TO REWIND AND WHEN THEY ATTEMPTED TO PRIME THE INSULIN PUMP ALL OF THE INSULIN WAS PUSHED OUT. CUSTOMER ADVISED THE DRIVE SUPPORT CAP WAS FLUSH. 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: No Consequences Or Impact To Patient

  MAUDE report 6787048 ↗

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