Paradigm® REAL-Time Revel™ MMT-523LNAP (UDI 00643169932975)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00643169932975), received between Dec 15, 2017 and May 28, 2020 — classified as 12 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (5 reports).

14 other recalls cover devices cleared under the same FDA submission (P150019, 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A PUMP ERROR ALARM. CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS NOT ABLE TO COMPLETE PUMP REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10095497 ↗
• MalfunctionApr 21, 2020Device Alarm System; Battery Problem; Device Alarm System; Battery Problem

  CUSTOMER'S PARENT REPORTED VIA PHONE CALL BEEP ANOMALY ON THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ADVISED THE BEEP IS VERY LOW AND THEY WERE UNABLE TO HEAR IT CLEARLY DURING THE SELF TEST. 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 9980152 ↗
• MalfunctionApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT DAUGHTER OF THE CUSTOMER HAD HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE OF CUSTOMER WAS 339 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE LEVEL EVENT. CUSTOMER WAS NOT ALLEGING INSULIN PUMP WAS UNDER DELIVERING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9941889 ↗
• MalfunctionJan 31, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. CUSTOMER REPORTED THAT THEY WERE UNABLE TO CLEAR THE ALARM. CUSTOMER STATED THAT THEY WERE ABLE TO REWIND THE INSULIN PUMP. CUSTOMER REPORTED THAT THE AFTER CHANGING THE BATTERY INSULIN PUMP RECEIVED ANOTHER ALARM. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9651739 ↗
• MalfunctionJan 21, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE HARDER TO PRESS, HAD TO PRESS ACT BUTTON MORE THAN ONCE FOR RESPONDING. THE CUSTOMER STATED THE INSULIN PUMP HAD FRACTURED ON FRONT, UNEXPLAINED OR RANDOM NO DELIVERY ALARMS. CUSTOMER DECLINED TROUBLESHOOTING. 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 9609356 ↗
• MalfunctionDec 12, 2019Premature Discharge of Battery; Failure to Cycle; Material Integrity Problem; Priming Problem; Premature Discharge of Battery; Failure to Cycle; Material Integrity Problem; Priming Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN WAS LEAKING OUT MORE THAN USUAL DURING LOADING OF RESERVOIR. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT CUSTOMER WAS CHANGING BATTERIES WITHIN SEVEN DAYS, INSULIN PUMP LOST SETTINGS AFTER CHANGING OUT BATTERIES AND BATTERY CAP WAS HARD TO LINE UP. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9456202 ↗
• MalfunctionNov 25, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  THE CUSTOMER'S HUSBAND REPORTED VIA PHONE CALL THAT THE RESERVOIR COMPARTMENT WAS CRACKED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE AND NOTICED THE RESERVOIR DID NOT LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. CUSTOMER WAS ADVISED TO THE INSULIN PUMP WOULD NEED TO BE REPLACED, TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9367823 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THEY HAD A HIGH BLOOD GLUCOSE VALUE OF 401 MG/DL. CUSTOMER'S OTHER BLOOD GLUCOSE VALUE WAS 200 MG/DL AND 300 MG/DL. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION AND INSULIN PUMP. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9189728 ↗
• MalfunctionOct 11, 2019Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER GETTING ALARM THAT SAID HAD A BLACK DOT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED ALARM WAS GOING OFF. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9178628 ↗
• MalfunctionSep 26, 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 297 MG/DL. CUSTOMER REPORTED THAT THE INSULIN PUMP TURNED OFF AT NIGHT AND SHE DID NOT RECEIVED INSULIN FOR A FEW HOURS. WHEN SHE WOKE UP HER BLOOD GLUCOSE WAS ALREADY HIGH. CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL WAS 314 MG/DL. CUSTOMER STATED THAT THE DISPLAY WAS NOT BLANK LESS THAN 30 SECONDS. CUSTOMER STATED THAT DISPLAY WAS BLANK CURRENTLY. CUSTOMER STATED THAT THE CONTACTS ON THE BATTERY CAP NEITHER MISSING NOR DAMAGED. DISPLAY DID NOT RETURN AFTER INSERTING NEW BATTERY. 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 NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9125002 ↗
• MalfunctionSep 17, 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 170 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP SHUT OFF AND SUDDENLY HAD NO DISPLAY. CUSTOMER CHANGED THE BATTERY 3 DAYS AGO THEN SUDDENLY THIS AFTERNOON IT WAS NOT WORKING ANYMORE. CUSTOMER STATES THE CONTACT ON THE BATTERY CAP WAS NEITHER MISSING NOR DAMAGE NOR CORRODED. CUSTOMER STATES BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATES THE SPRING WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THAT DISPLAY DID NOT RETURN AFTER PUMP 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 9074285 ↗
• MalfunctionJul 10, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP BUTTONS WERE UNRESPONSIVE. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8774912 ↗
• InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED NO DELIVERY ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 411 MG/DL AT THE TIME OF INCIDENT. CUSTOMER TREATED WITH MANUAL INJECTIONS AND BLOOD GLUCOSE LEVEL WENT DOWN TO 175 MG/DL. THE CUSTOMER ALSO REPORTED HAVING SKIN IRRITATION DUE TO INFUSION SET. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8714228 ↗
• MalfunctionApr 30, 2019Break; Crack

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. CUSTOMER STATED THE RESERVOIR LIP ALMOST CRACKED COMPLETELY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 190 MG/DL AT THE TIME OF THE CALL. CUSTOMER STATED THE RESERVOIR STILL LOCKS INTO PLACE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8567320 ↗
• MalfunctionApr 23, 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 UNKNOWN AT THE TIME OF THE INCIDENT. 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 8538882 ↗
• MalfunctionFeb 8, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR LIP RING WAS UNABLE TO LOCK. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8319705 ↗
• MalfunctionFeb 8, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Connection Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Connection Problem; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO STATED THAT BUTTONS ARE HARDER TO PRESS AND STICK. CUSTOMER STATES INSULIN PUMP PIECES WAS BROKEN OFF AND PLASTIC PIECE CHIPPED OFF. CUSTOMER STATES INSULIN PUMP HAD MOTOR SLUGGISH DURING REWIND. CUSTOMER ALSO REPORTS INSULIN PUMP HAD RANDOM UNEXPLAINED NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8319442 ↗
• MalfunctionFeb 5, 2019Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD UNEXPECTED RESTART. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 129 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS REPORTED THAT THE ALARM WAS OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. THE CUSTOMER WAS REPORTED THAT THE ALARM WAS RECURRING DURING NORMAL PUMP USE. THE CUSTOMER WAS ALSO ADVISED THAT THE INSULIN PUMP WILL BE REPLACED AND MAY CONTINUE TO WEAR THE PUMP UNTIL REPLACEMENT ARRIVES. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8308097 ↗
• InjuryJan 25, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AS WELL AS DIABETIC KETOACIDOSIS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL, 440 MG/DL AT TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE LEVEL WAS 153 MG/DL, 161 MG/DL. CUSTOMER REPORTS THE FOLLOWING SYMPTOMS RELATED TO THEIR HIGH BLOOD GLUCOSE SUCH AS REALLY SICK AND THREW UP. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED WITH INSULIN PUMP FOR HIGH BLOOD GLUCOSE. CUSTOMER REPORTS THEY DID NOT CONTACT THEIR HEALTH CARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE. CUSTOMER DID NOT ALLEGE POSSIBLE INSULIN PUMP WAS UNDER DELIVERY. CUSTOMER STATES THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER WAS ABLE TO PERFORM HIGH PRESSURE TEST AT THAT TIME. CUSTOMER REPORTS THEY PERFORMED THE HIGH PRESSURE TEST AND FULL 5 UNITS WENT THROUGH BUT NO ALARM. CUSTOMER REPORTS THEY REPEATED HIGH PRESSURE TEST AND WENT THROUGH 5 UNITS NO ALARM AND NO INSULIN CAME OUT OF TUBING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8277142 ↗
• InjuryJan 25, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL, 440 MG/DL AT TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE LEVEL WAS 161 MG/DL. CUSTOMER REPORTS THE FOLLOWING SYMPTOMS RELATED TO THEIR HIGH BLOOD GLUCOSE SUCH AS REALLY SICK AND THREW UP. 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 POSSIBLE INSULIN PUMP WAS UNDER DELIVERY. CUSTOMER STATES THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER REPORTS INSULIN EXITED AT THE QUICK RELEASE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Vomiting

  MAUDE report 8276957 ↗
• MalfunctionDec 2, 2018Premature Discharge of Battery; Premature Discharge of Battery

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART, A COLD RESET WAS PERFORMED ALARM. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM AND ABLE TO COMPLETE REWIND. CUSTOMER STATES A TEMPERATURE BASAL WAS NOT PROGRAMMED BEFORE THE ALARM OCCURRED. CUSTOMER STATES THE INSULIN PUMP WAS NOT STORED OR NOT IN USE FOR AN EXTENDED PERIOD OF TIME. CUSTOMER STATED ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. ADVISED CUSTOMER TO REMOVE THE CURRENT BATTERY FROM THE PUMP AND INSERT A NEW BATTERY AND AGAIN PUMP ERROR OCCURRED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8123356 ↗
• MalfunctionOct 24, 2018Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE ACT BUTTON WAS NOT WORKING AND TIME WAS NOT ADVANCING ON THE INSULIN PUMP. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 134 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND THEY STATED THAT THE NO TIME ADVANCED. 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 7998310 ↗
• InjurySep 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 251 MG/DL,194 MG/DL,600 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN PUMP. BASED ON CUSTOMER REPORT CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. THE DRIVE SUPPORT CAP APPEARS LOOSE. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7901139 ↗
• InjurySep 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE TWICE DUE TO LOW BLOOD GLUCOSE, WITH BLOOD GLUCOSE OF 21 MG/DL AT THE TIME OF ONE OF THE INCIDENTS. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED. THE CUSTOMER WAS NOT USING SENSORS DUE TO A BROKEN TRANSMITTER, AND WENT LOW SINCE THEY DO NOT FEEL THEIR LOWS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7841045 ↗
• MalfunctionApr 24, 2018Break; Detachment Of Device Component; Crack

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 150 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE LIP RING OF THE RESERVOIR WAS CRACKED AND THE O-RING CAME OUT. THE CUSTOMER ALSO STATED THAT THE RESERVOIR WAS UNABLE TO LOCK INTO PUMP. 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 7457046 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150019, 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-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-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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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