PARADIGM® REAL-time MMT-522NAP (UDI 00613994622662)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994622662), received between Nov 27, 2017 and Oct 30, 2019 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED A BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE TIME WAS MOVING FORWARD. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF INSULIN PUMP AND REVERT TO BACKUP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256584 ↗
• MalfunctionOct 29, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED A BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE TIME WAS MOVING FORWARD. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF INSULIN PUMP AND REVERT TO BACKUP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9252044 ↗
• MalfunctionSep 16, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED A BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE TIME WAS MOVING FORWARD. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF INSULIN PUMP AND REVERT TO BACKUP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9074132 ↗
• MalfunctionAug 9, 2019Display or Visual Feedback Problem; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SCREEN HAD SCRATCHES THAT IMPAIRED THE VISIBILITY OF THE SCREEN. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE INSULIN WAS REJECTING NEW BATTERIES, THERE WAS CRACKS AROUND RESERVOIR WINDOW, CRACK BY BATTERY COMPARTMENT AND IT WAS GLUED TOGETHER. THE TROUBLESHOOTING WAS NOT MENTIONED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8877256 ↗
• MalfunctionJul 11, 2019Failure to Cycle; Failure to Cycle

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPRISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 163 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THEY WERE UNABLE TO EXIT PREPARING TO PRIME LOOP. CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT DURING MANUAL PRIME. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8779654 ↗
• MalfunctionJun 4, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 111 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THEY HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8665842 ↗
• MalfunctionMar 27, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 76 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATES THAT DAMAGE OCCURRED DUE TO SMALL CRACK ON THE PUMP ON THE UPPER RIGHT AROUND THE TYPE OF THE DISPLAY SCREEN. 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: No Consequences Or Impact To Patient

  MAUDE report 8455799 ↗
• MalfunctionJun 13, 2018Crack

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A QUIT WORKING. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 133 MG/DL. CUSTOMER STATED THE DEVICE WAS NO LONGER WORKING AND THERE WERE CRACKS ON THE SCREEN. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7597365 ↗
• InjuryFeb 21, 2018Scratched Material

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 418 MG/DL AND AFTER CORRECTION IT WENT DOWN TO 275 MG/DL. AT 11:36 BLOOD GLUCOSE WAS 220 MG/DL AND AFTER CARB INTAKE AT 1:35 IT WAS 301 MG/DL AND CURRENT BLOOD GLUCOSE IS 307 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING ON INSULIN PUMP. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. THE CUSTOMER WAS NEITHER HOSPITALIZED NOR ADMITTED FOR HIGH BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING AND DRIVE SUPPORT CAP WAS NORMAL. IT WAS ALSO REPORTED THAT THE THERE WAS SCRATCHES ON THE INSULIN PUMP SCREEN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7287497 ↗
• InjuryDec 26, 2017Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY WENT TO EMERGENCY ROOM DUE TO KETONES. CUSTOMER¿S BLOOD GLUCOSE WAS 381 MG/DL AT TIME OF INCIDENT. CUSTOMER DECLINED TROUBLESHOOT FOR ISSUES WITH INSULIN PUMP AND TREATED WITH MANUAL INJECTIONS. INSULIN PUMP WILL NOT BE RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7145849 ↗
• MalfunctionNov 27, 2017Loose or Intermittent Connection; Device Displays Incorrect Message

  IT WAS REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED A COMPROMISED FORCE SENSOR SYSTEM DURING A SET CHANGE. THE INSULIN PUMP WAS NOT BUMPED OR DROPPED. THE DRIVE SUPPORT CAP WAS LOOSE. THE CUSTOMER DID NOT RECALL PRESSING THE CAP WHILE CONNECTED. THE CUSTOMER¿S BLOOD GLUCOSE DURING THE INCIDENT WAS 229 MG/DL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7062158 ↗

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-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• Z-1749-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
• 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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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-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-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-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