Paradigm® REAL-Time Revel™ MMT-523LNAP (UDI 00643169479623)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00643169479623), received between Jun 8, 2017 and Jun 8, 2020 — classified as 8 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCED SENSOR SYSTEM ERROR ALARM. 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 10127459 ↗
• MalfunctionFeb 4, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM AT THE TIME OF PRIME REWIND. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER STATED THAT DURING SEATING THE FORCE SENSOR DID NOT DETECTED THE RESERVOIR. 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 9663849 ↗
• MalfunctionMar 29, 2019No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 117 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND CUSTOMER REPORTS DISPLAY WAS BLANK CURRENTLY. CUSTOMER STATES THE DISPLAY WAS NOT BLANK LESS THAN 30 SECONDS AND DID NOT RETURN. ADVISE CUSTOMER TO REMOVE THE BATTERY AND CUSTOMER STATED THE INSERT BATTERY ALARM DID NOT DISPLAY ON THE INSULIN PUMP SCREEN. CUSTOMER STATES THE CONTACT ON THE BATTERY CAP WAS NOT MISSING OR DAMAGE OR CORRODED. CUSTOMER STATES BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATES THE SPRING WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATES THE DISPLAY DID NOT RETURN AFTER INSULIN PUMP RESTART. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE CUSTOMER WAS ADVISED THE INSULIN PUMP WILL BE REPLACED AS PER TROUBLESHOOT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464172 ↗
• MalfunctionDec 19, 2018Connection Problem; Connection Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE LIP RING OF THE RESERVOIR COMPARTMENT WAS UNABLE TO LOCK IN PLACE WHEN INSERTED INTO THE INSULIN PUMP. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. DURING TROUBLESHOOTING, THE CUSTOMER STATED THAT THE RESERVOIR LIP RING WAS CRACKED AND MISSING PIECES OF PLASTIC. 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 8177679 ↗
• InjuryJun 23, 2018Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF INCIDENT. THE CURRENT BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NOT FEELING GOOD. THE CUSTOMER TREATED WITH INJECTION. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7632443 ↗
• MalfunctionMar 30, 2018Break

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BOTTOM OF PUMP COMING OFF. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WILL RETURN DEVICE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7387116 ↗
• InjuryDec 20, 2017Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 470 MG/DL. THE CUSTOMER HAD SYMPTOMS LIKE NAUSEA. THE CUSTOMER WAS TREATED WITH PUMP BOLUS. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 470 MG/DL AT TIME OF INCIDENT. CUSTOMER'S CURRENT BLOOD GLUCOSE VALUE WAS 77 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICE DISPATCHED AS A RESULT OF HIGH BLOOD GLUCOSE. DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER DECLINED TO CHECK FOR THE PRESENCE OF LEAKS OR AIR BUBBLES IN THE TUBING/RESERVOIR. CUSTOMER DECLINED TO CHECK FOR POSSIBLE SITE/INSULIN ISSUES. CUSTOMER DECLINED TO PERFORM THE HIGH PRESSURE TEST. CUSTOMER WAS EXPLAINED ABOUT THE 2 HIGH BLOOD GLUCOSE RULE. CUSTOMER WAS ADVISED TO CHANGE THE INFUSION SET, RESERVOIR AND INSULIN AND TO TREAT PER HEALTHCARE PROFESSIONAL'S RECOMMENDATION THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7134693 ↗
• MalfunctionNov 27, 2017Break; Component Falling; Unable to Obtain Readings

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS RAN OVER BY CAR AND DROPPED AND WHOLE INSULIN PUMP WAS BROKEN. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 223 MG/DL. THE CUSTOMER REPORTED THAT THE CUSTOMER WAS NOT ABLE TO READ THE SCREEN SINCE INSULIN PUMP BROKEN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF INSULIN PUMP. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7059983 ↗
• MalfunctionNov 22, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR AND NO DELIVERY. THE CUSTOMER WAS ASSISTED WITH MOTOR ERROR TROUBLESHOOTING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE DRIVE SUPPORT CAP APPEARED NORMAL. THE CUSTOMER STATED THAT THEY HAD AN X-RAY ON THEIR FINGER WHILE HAVING THE INSULIN PUMP ON. THE CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND, BUT THE ALARM HISTORY CONTAINED MORE THAN ONE MOTOR ERROR ALARM WITHIN THE LAST 30 DAYS. 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. TROUBLESHOOTING FOR NO DELIVERY WAS DECLINED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7054867 ↗
• MalfunctionOct 13, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND A MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 238 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING INFUSION SET CHANGE. CUSTOMER ALSO REPORTED TO HAVE RECEIVED A COMPROMISED FORCE SENSOR SYSTEM WHILE TROUBLESHOOTING FOR MOTOR ERROR. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THEY WERE ABLE TO COMPLETE THE REWIND PROCESS. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6949972 ↗
• MalfunctionSep 21, 2017Device Displays Incorrect Message; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. CUSTOMER STATES INSULIN CONTINUES TO DRIP AFTER MOTOR STOPS DURING THE MANUAL PRIME PROCESS . CUSTOMER STATES THEY ARE UNABLE TO EXIT THE "PREPARING TO PRIME" LOOP. CUSTOMER STATES THE REWIND MESSAGE OCCURRED AFTER AN ALARM/ALERT. CUSTOMER STATES THEY ARE STUCK IN REWIND COMPLETE/BOLUS DELIVERY LOOP. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. 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 6885130 ↗
• MalfunctionSep 7, 2017Device Displays Incorrect Message

  THE CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAS A AND E ALARMS AFTER BATTERY CHANGE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 125 MG/DL AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL RESET THE TIME AND DATE AND ASKS TO REDO THE RESERVOIR. TROUBLESHOOTING WAS PERFORMED AND REVIEWED THE ALARM HISTORY AND FOUND EXTERNAL RAM CRC ERROR. ALARM DID NOT OCCUR DURING THE REWIND/PRIME SEQUENCE. ASSISTED CUSTOMER IN PERFORMING A SELF-TEST AND THE TEST PASSED. 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 6850163 ↗
• MalfunctionAug 1, 2017Break; Device Slipped

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH AND LOW BLOOD GLUCOSE LEVELS. CUSTOMER ALSO REPORTED THAT THE RESERVOIR COMPARTMENT OF THE DEVICE WAS DAMAGED AND THE RESERVOIR WOULD NOT LOCK INTO PLACE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 300 MG/DL WHICH WAS TREATED WITH A BOLUS. THE FOLLOWING MORNING, THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 50 MG/DL AFTER TAKING A BOLUS AT 7:00 AM. CUSTOMER TREATED WITH FOOD AND GLUCOSE TABLET. CUSTOMER DECLINED TROUBLESHOOTING. THE CUSTOMER WAS ADVISED THE INSULIN PUMP WILL BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 6756556 ↗
• MalfunctionJul 28, 2017Component Falling

  THE CUSTOMER CALLED VIA PHONE AND STATES THAT SHE WAS CHANGING HER INFUSION SET AND AN O RING FELL OUT OF THE RESERVOIR COMPARTMENT. THE CUSTOMER'S BLOOD GLUCOSE WAS 226 MG/DL. THE INSULIN PUMP WILL RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6750746 ↗
• InjuryJul 12, 2017Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2017 WITH BLOOD GLUCOSE OF 207 MG/DL AND TREATED WITH IV FLUIDS. CUSTOMER'S BLOOD GLUCOSE WAS 388 MG/DL PRIOR TO HOSPITALIZATION AND WAS TREATED WITH MANUAL INJECTION AND INSULIN PUMP. CUSTOMER'S CURRENT BLOOD GLUCOSE READING WAS AT 200 MG/DL. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS LARGE KETONES. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. CUSTOMER'S PARENT ALSO REPORTED THAT THE INSULIN PUMP HAD A NO DELIVERY AND MOTOR ERROR ALARM AND WAS ABLE TO COMPLETE THE TROUBLESHOOTING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 6709377 ↗
• InjuryJul 12, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND A NO DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 411 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING BOLUS DELIVERY AND THEN MOTOR ERROR. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS AND WAS NOT ABLE TO COMPLETE THE REWIND PROCESS. CUSTOMER ALSO MENTIONED A HIGH BLOOD GLUCOSE OF 411 MG/DL AND TREATED WITH MANUAL INJECTION. CUSTOMER DECLINED HIGH BLOOD GLUCOSE AND NO DELIVERY TROUBLESHOOTING . 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 6709001 ↗
• InjuryJun 29, 2017Insufficient Device Problem Information

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL OF 50 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE READING. CUSTOMER STATES LOW BLOOD GLUCOSE READING WAS TREATED BY EATING FOOD AND GLUCOSE TABLET. CUSTOMER INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 6679216 ↗
• InjuryJun 20, 2017Failure to Deliver

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN. CUSTOMER'S BLOOD GLUCOSE LEVEL WENT UP TO 455 MG/DL. THE CUSTOMER TREATED WITH THE INSULIN PUMP TO DELIVER A BOLUS AND WITH AN INJECTION SHOT. CUSTOMER'S BLOOD GLUCOSE LEVEL DROPPED TO 34 MG/DL. THE CUSTOMER TREATED THEIR LOW BLOOD GLUCOSE LEVEL WITH FOOD. THE DEVICE WAS NOT RETURNED.

  Patient problems: Hyperglycemia

  MAUDE report 6655902 ↗
• InjuryJun 20, 2017Adverse Event Without Identified Device or Use Problem

  CLARIFICATION: THE EVENT TOOK PLACE ON (B)(6) 2017.

  Patient problems: Hypoglycemia

  MAUDE report 6654782 ↗
• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE. WITH BLOOD GLUCOSE OF 34 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER'S LEVEL AT THE TIME OF THE CALL WAS 455 M/DL. THE CUSTOMER WAS GIVEN A PEANUT BUTTER AND JELLY SANDWICH TO TREAT. THE CUSTOMER HAD ANOTHER LOW BLOOD GLUCOSE A YEAR AND A HALF AGO. THE CUSTOMER WAS AT 20 MG/DL WHEN THE PARAMEDICS GOT TO HER. THE CUSTOMER HAD BEEN SLEEPING, WOKE UP AND WAS WALKING AROUND HER ROOM AS SHE COULD NOT FIND THE DOOR. SHE PASSED OUT AS SHE WAS LOOKING FOR ORANGE JUICE TO TREAT. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENTS. TROUBLESHOOTING WAS COMPLETED AND THE CUSTOMER STATES THAT HER PUMP UNDER-DELIVERS INSULIN. CUSTOMER STATES THAT WHEN HER BLOOD GLUCOSE DROPS TO 70 MG/DL IT DROPS VERY QUICKLY FROM THERE. CUSTOMER HAS BEEN IN AN ACCIDENT WHILE WEARING THE PUMP, NOT AN A DIFFERENT OCCASION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 6621560 ↗

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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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-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