PARADIGM® REAL-time MMT-522NAL (UDI 00613994402110)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00613994402110), received between Jun 8, 2017 and Jul 7, 2020 — classified as 6 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (4 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2020Display or Visual Feedback Problem; Mechanical Problem; Patient Device Interaction Problem; Priming Problem; Display or Visual Feedback Problem; Mechanical Problem; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP SCREEN HAD SCRATCHES AND CUSTOMER WAS GETTING HARD TO READ THE SCREEN. MOTOR WAS WORKED INTERMITTENTLY SOMETIMES WOULD BE WORK SLOWLY. INSULIN SQUIRTED OUT DURING PRIMING. TOOK LONGER TIME TO REWIND. THE BACKLIGHT WAS DIMMER. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10238947 ↗
• MalfunctionApr 17, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  CUSTOMER REPORTED VIA PHONE CALL POSSIBLE UNDER DELIVERY ON THE INSULIN PUMP. TROUBLESHOOTING WAS UNABLE TO BE PERFORMED. CUSTOMER ADVISED IT TOOK FOUR HOURS FOR A BOLUS DELIVERY TO TAKE FULL EFFECT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9975340 ↗
• MalfunctionNov 25, 2019Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED HARD WARE LOW LEVEL ALARM. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 159 MG/DL. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND. CUSTOMER REPORTED THAT AFTER TROUBLESHOOTING THE ALARM OCCURRED. THE INSULIN PUMP WILL NOT BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9368014 ↗
• MalfunctionSep 10, 2019Device Alarm System; Power Problem; Patient Device Interaction Problem; Device Alarm System; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NO LONGER GIVING LOW BATTERY WARNING. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE INSULIN PUMP WAS NOT ALWAYS GIVING INSULIN WHEN PUTTING BOLUS REQUEST AND INSULIN PUMP WAS REJECTING NEW BATTERY. THE CUSTOMER DECLINED THE TROUBLESHOOTING WITH THE TECHNICAL SUPPORT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8979467 ↗
• MalfunctionJul 25, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED TO THE INSULIN PUMP WOULD NEED TO BE REPLACED AND REVERT TO BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8825559 ↗
• MalfunctionJul 1, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Device Difficult to Program or Calibrate; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED VIA PHONE CALL ON (B)(6) 2018 THAT THE BUTTONS OF THE INSULIN PUMP ARE HARD TO PRESS AND MAY HAVE WORN OUT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED ISSUES WITH BATTERY LONGEVITY AND RANDOM NO DELIVERY ALARMS. TROUBLESHOOTING DID NOT OCCUR. PRODUCT WILL NOT RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8747630 ↗
• InjuryJan 8, 2019Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AS WELL AS GETTING NO DELIVERY ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE LEVEL WAS 397 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. CUSTOMER REPORTS THE SYMPTOMS RELATED TO THEIR HIGH BLOOD GLUCOSE SUCH AS CUSTOMER STATED THEY WAS SICK. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED WITH MANUAL INJECTION FOR HIGH BLOOD GLUCOSE. CUSTOMER REPORTS THEY DID NOT CONTACT THEIR HEALTH CARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE. CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER STATES THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER STATES BATTERY LASTED MORE THAN ONE WEEK. CUSTOMER DECLINED TO TROUBLESHOOTING FOR NO DELIVERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS

  Patient problems: Hyperglycemia

  MAUDE report 8225145 ↗
• MalfunctionDec 4, 2018Computer Software Problem; Computer Software Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE DEVICE HAS STOPPED WORKING. REPORT DOES NOT STATE WHETHER THE RESERVOIR IS ABLE TO LOCK INTO PLACE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT IS 127 MG/DL. NO FURTHER DETAILS OR INFORMATION AVAILABLE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8127612 ↗
• InjuryNov 30, 2018No Apparent Adverse Event; Priming Problem; No Apparent Adverse Event; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PRIME ANOMALY AND REWIND ANOMALY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ADVISED TO DISCONTINUED THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8118932 ↗
• MalfunctionAug 14, 2018Power Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY GOT BATTERY FAILED ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 252MG/DL. TROUBLESHOOTING WAS NOT PERFORMED. THE PRODUCT WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7779885 ↗
• MalfunctionAug 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED WITH A COMPROMISED FORCE SENSOR SYSTEM DURING THE PRIMING PROCESS. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF INCIDENT IS UNKNOWN. TROUBLESHOOTING WAS INITIATED FOR THE REWIND AND PRIME ISSUE. THE DRIVE SUPPORT CAP WAS FLUSH. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL¿S INSTRUCTION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7743438 ↗
• InjuryMar 15, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 451 MG/DL. THE CUSTOMER ALSO REPORTED NO DELIVERY ALARM ON INSULIN PUMP. CUSTOMER STATED SHE HAD BLOOD AT SITE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7344035 ↗
• MalfunctionJan 16, 2018Component Falling; Moisture or Humidity Problem; Reset Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATES SLIPPED ON ICE AND FELL. PUMP WOULD NOT RESTART. 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 7194666 ↗
• MalfunctionOct 18, 2017Device 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 92 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. 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 IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6958875 ↗
• InjuryOct 10, 2017Insufficient Device Problem Information

  IT WAS REPORTED BY A DIABETES CLINICAL SUPERVISOR THAT THE CUSTOMER GOT HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2017 WITH UNKNOWN BLOOD GLUCOSE LEVELS AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 6939198 ↗
• MalfunctionSep 27, 2017Break; Detachment Of Device Component; Crack; Sticking; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DAMAGED. THE CUSTOMER STATED THAT THE COVER HAS FALLEN OFF AND THAT WIRES WERE VISIBLE. IT WAS ADDED THAT THE SEAL ON THE END HAD COME UNDONE AS WELL AND THAT THE INSULIN PUMP WAS ALSO STUCK IN THE REWIND FUNCTION. TROUBLESHOOTING FOR THE DAMAGE WAS PERFORMED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THERE WAS ALSO A CRACK IN ADDITION TO THE DAMAGED MENTIONED BUT ALSO STATED THAT THEY DID NOT KNOW ANY SPECIFIC EVENTS ON HOW THE DAMAGES OCCURRED. 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 WAS RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6899233 ↗
• InjurySep 20, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND SUGAR WAS OVER 507MG/DL. THE CURRENT BLOOD GLUCOSE LEVEL WAS 347MG/DL. THE CUSTOMER EXPERIENCED SYMPTOM SUCH AS VOMITING. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER GOT ALARM FOR ALARMED COMPROMISED FORCE SENSOR SYSTEM DURING PRIMING. TROUBLESHOOT DID NOT RESOLVE THE ISSUE. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6880367 ↗
• MalfunctionSep 15, 2017No Display/Image; Component Missing

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 348 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND THE DISPLAY DID NOT RETURN. THE CUSTOMER REPORTED THAT PIECES MISSING ON TOP OF BATTERY COMPARTMENT. CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH PUMP. CUSTOMER DECLINE TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6871355 ↗
• InjuryJun 26, 2017Device Displays Incorrect Message

  THE CUSTOMER¿S SPOUSE REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE. THE INSULIN PUMP WAS NOT GIVING THEM A NO DELIVERY ALARM. THEY WOULD KNOW THEY WERE HIGH FROM THE METER OR WHEN THEY START FEELING SYMPTOMS OF HIGH BLOOD GLUCOSE. THE CUSTOMER FELT THAT THE ISSUES HAD TO DO WITH REMOVING THE SET WHILE IN THE SHOWER. THE CUSTOMER NOTICED THAT AFTER SHE RECONNECTS AND TREATS HER BLOOD GLUCOSE, INSTEAD OF GOING BACK TO NORMAL THEY WOULD START TO GO UP. THE CUSTOMER HAD TREATED 8-9 TIMES WITH THE INSULIN PUMP BUT THEIR BLOOD GLUCOSE STILL WOULD NOT GO DOWN UNTIL THEY TREATED WITH A MANUAL SYRINGE AND AN INFUSION SET CHANGE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 500 MG/DL. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 278 MG/DL. THE CUSTOMER STATED THEY WILL CALL BACK TO TROUBLESHOOT WHEN IT WAS TIME TO REMOVE THE SET FROM THEIR BODY. THE CUSTOMER DID NOT WANT TO DISCONNECT FROM THE INSULIN PUMP DURING THE CALL BECAUSE THEIR BLOOD GLUCOSE LEVELS WERE NORMAL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6667841 ↗
• MalfunctionJun 13, 2017Inaccurate Delivery; Application Program Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED WITH A COMPROMISED FORCE SENSOR SYSTEM DURING THE PRIMING PROCESS; INSULIN SQUIRTED FROM THE TUBING. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF INCIDENT WAS 165 MG/DL. TROUBLESHOOTING WAS INITIATED FOR THE REWIND AND PRIME ISSUE. THE INSULIN PUMP WAS NOT BUMPED OR DROPPED PRIOR TO THE ALARM. THE DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL¿S INSTRUCTION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6637592 ↗
• MalfunctionJun 8, 2017Device Operates Differently Than Expected

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTON STOP WORKING. CUSTOMER DID NOT RECALL BLOOD GLUCOSE AT THE TIME OF INCIDENT. CUSTOMER CANNOT RECALL THE CAUSE OF THE ISSUE. TROUBLESHOOT WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6621807 ↗

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-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-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-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-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