PARADIGM® REAL-time MMT-522NAB (UDI 00613994372024)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994372024), received between Aug 31, 2017 and Nov 22, 2019 — classified as 1 death, 9 malfunctions.

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

• MalfunctionNov 22, 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 127 MG/DL AT THE TIME OF THE INCIDENT AND TOOK MANUAL INJECTION. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. 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 BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9363047 ↗
• MalfunctionOct 31, 2019Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WOULD NOT DELIVER INSULIN. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THERE WAS A HAIRLINE FRACTURE AT THE BASE OF RESERVOIR COMPARTMENT. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9260633 ↗
• MalfunctionOct 1, 2019Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BOTTOM OF PUMP WAS TAPED TOGETHER BECAUSE CRACK WASN'T HOLDING TOGETHER. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED CRACK BY BATTERY COMPARTMENT AND CRACK AT TOP OF RESERVOIR. CUSTOMER DECLINED TO SPEAK WITH TECHNICAL SUPPORT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9138615 ↗
• MalfunctionFeb 26, 2019Patient Device Interaction Problem; Priming Problem; Patient Device Interaction Problem; Priming Problem

  IT WAS REPORTED THAT THE INSULIN PUMP HAD PRIME REWIND ANOMALY. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 126 MG/DL. CUSTOMER REPORTED A CRACKED IN THE DISPLAY. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATES INSULIN PUMP DOES NOT REWIND. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8372710 ↗
• MalfunctionFeb 19, 2019No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 182 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT WORKING AND NOT TURNING ON. THE TROUBLESHOOTING WAS PERFORMED AND WAS ADVISED TO INSERT NEW BATTERY AND DISPLAY DID NOT RETURNED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8349063 ↗
• MalfunctionSep 6, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP'S DRIVE SUPPORT CAP WAS LOOSE. THE CUSTOMER PRESSED DOWN THE BUTTON AND OVER-DELIVERED INSULIN. THE CUSTOMER STATED THAT HE HAD A NEAR-DEATH EXPERIENCE DUE TO HYPOGLYCEMIA. HE TREATED WITH A CUP OF SUGAR. TROUBLESHOOTING DID NOT OCCUR FOR THE INSULIN PUMP. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7853506 ↗
• MalfunctionDec 28, 2017Device Displays Incorrect Message; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 180 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. CUSTOMER ALSO REPORTED THAT HE HAD A HIGH BLOOD GLUCOSE OF IN THE 300 MG/DL BECAUSE HE TOOK THE INSULIN PUMP OFF AND USED MANUAL INJECTION FOR TREATMENT. 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: Hyperglycemia

  MAUDE report 7151480 ↗
• DeathDec 15, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME. THE CUSTOMER WAS HOSPITALIZED IN (B)(6) 2017 FOR 3 DAYS. THE CAUSE OF DEATH WAS DIABETES COMPLICATIONS. THE CALLER STATED THAT THE CUSTOMER HAD HEART ISSUES AND FAILING KIDNEYS THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Death

  MAUDE report 7122453 ↗
• MalfunctionAug 31, 2017Device Slipped; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER WAS ASSISTED WITH MOTOR ERROR TROUBLESHOOTING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 112 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS LOOSE. THE CUSTOMER ALSO STATED THAT THE BOTTOM COVER OF THE INSULIN PUMP, WHERE THE DOME STICKER WAS, BECAME LOOSE AS WELL. THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. THE CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. 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 BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6835218 ↗
• MalfunctionAug 31, 2017Fluid/Blood Leak; Device Displays Incorrect Message; Material Deformation

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 122 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED HAVING A PROBLEM, TRYING TO REWIND AND PRIME THE INSULIN PUMP. THE CUSTOMER REPORTED THE INSULIN WAS "SQUIRTING OUT" DURING THE MANUAL PRIME PROCESS. THE DRIVE SUPPORT DISK IS NORMAL SLIGHTLY INDENTED. THE CUSTOMER DID TROUBLESHOOT THE ISSUE. 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 6835012 ↗

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