Paradigm® REAL-Time Revel™ MMT-723RNAB (UDI 00643169476561)Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00643169476561), received between Jun 5, 2017 and Jul 31, 2020 — classified as 31 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (17 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 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2020Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED THAT EMERGENCY MEDICAL SERVICES WERE DISPATCHED AND WAS HOSPITALIZED DUE HIGH BLOOD GLUCOSE ON (B)(6) 2020 TO (B)(6) 2020. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS OVER 500 MG/DL AND WHEN ADMITTED TO HOSPITAL WAS 542 MG/DL AND THEN HIGHER. CUSTOMER STATED THAT HAD MOTOR ERROR ALARMS ON THE INSULIN PUMP. CUSTOMER STATED THAT SHE WAS IN THE HOSPITAL AND SHE TOOK THE INSULIN PUMP OFF DURING MAGNETIC RESONANCE IMAGING. CUSTOMER STATED THAT THEY WERE NAUSEATED, THROWING UP, TEMPERATURE WAS 99°F THEN 102°F. CUSTOMER HAD A DIABETIC ULCER THAT LED TO AN INFECTION. CUSTOMER STATED THAT SHE WAS TREATED IN EMERGENCY ROOM AND ADMITTED BLOOD GLUCOSE 542 MG/DL AND THEN HIGHER AND EARLIER AT HOSPITAL IT WAS BLOOD GLUCOSE 167 MG/DL. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED FOR HIGH BLOOD GLUCOSE WITH BOLUS AND INTRAVENOUS INJECTION AND ADMITTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Nausea; Ulcer; Vomiting

  MAUDE report 10348608 ↗
• InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE, NAUSEA AND VOMITING ON (B)(6) 2020. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WERE 167 MG/DL, OVER 500 MG/DL AND 542 MG/DL AT THE TIME OF HOSPITALIZATION. CUSTOMER HAD USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS TREATED WITH INTRAVENOUS. INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS TREATED WITH DRIP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Nausea; Vomiting

  MAUDE report 10348604 ↗
• InjuryJul 29, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT EMERGENCY MEDICAL SERVICES WAS DISPATCHED, THEY WERE IN EMERGENCY ROOM AND HOSPITALIZED DUE TO HYPERGLYCEMIA, DIABETIC ULCER AND AN INFECTION FROM (B)(6) 2020. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 542 MG/DL AT TIME OF INCIDENT. ANOTHER BLOOD GLUCOSE LEVEL WAS 167 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH INSULIN PUMP. THE CUSTOMER STATED THAT THE SYMPTOMS RELATED TO HIGH BLOOD GLUCOSE SUCH AS FEVER, NAUSEA AND VOMITING. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Fever; Hyperglycemia; Nausea; Ulcer; Unspecified Infection; Vomiting

  MAUDE report 10337490 ↗
• MalfunctionMar 18, 2020Mechanical Problem; Obstruction of Flow; Battery Problem; Power Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD SUDDEN POWER DOWN. CUSTOMER STATED INSULIN PUMP HAD NO DELIVERY ALARM, FREQUENT BATTERY WERE CHANGES, SLOW TO REWIND, HAD TO RESTART TO COMPLETE REWIND. 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 9848017 ↗
• MalfunctionMar 5, 2020Device Difficult to Program or Calibrate; Battery Problem; Device Difficult to Program or Calibrate; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS HAD TO BE PRESSED HARDER. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD SIX DAYS OR LESS BATTERY LIFE. 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 9791121 ↗
• InjuryFeb 26, 2020Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD MOTOR ERROR. IT WAS REPORTED THAT THEY WERE ABLE TO REWIND THE INSULIN PUMP. DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9754614 ↗
• InjuryJan 31, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  NURSE REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED HYPOGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 29 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS TREATED WITH GLUCOSE FOR LOW BLOOD GLUCOSE LEVEL. CUSTOMER HAD USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER STATED DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED THAT BATTERY CAP WAS "POOING" OFF AND THE RESERVOIR COMPARTMENT HAD CRACKED. CUSTOMER STATED RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. THE INSULIN PUMP WILL RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9652301 ↗
• MalfunctionDec 24, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9516499 ↗
• MalfunctionNov 16, 2019Display or Visual Feedback Problem; Obstruction of Flow; Patient Device Interaction Problem; Display or Visual Feedback Problem; Obstruction of Flow; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE CHIP BROKEN OFF ON RESERVOIR COMPARTMENT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALERTS AND BACKLIGHT WAS DIMMER. CUSTOMER DECLINED TO REPORT TO 24 HOURS TECHNICAL SUPPORT TEAM. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9332763 ↗
• MalfunctionOct 30, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED UNEXPLAINED NO DELIVERY ALERTS NOT DUE TO SITE ISSUES. CUSTOMER DECLINED TO REPORT TO MEDTRONIC 24 HOUR TECHNICAL SUPPORT DEPARTMENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9254161 ↗
• MalfunctionOct 30, 2019Device Difficult to Program or Calibrate; Battery Problem; Loss of Data; Device Difficult to Program or Calibrate; Battery Problem; Loss of Data

  CUSTOMER REPORTED VIA PHONE CALL THAT BUTTONS OF INSULIN PUMP WERE HARD TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT INSULIN PUMP HAD PUMP ERROR ALARM AND CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO COMPLETE REWIND. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9254128 ↗
• MalfunctionOct 23, 2019Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; No Apparent Adverse Event; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP'S SCREEN WAS HARDER TO READ AND KEYPAD ANOMALY. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER REPORTED THAT INSULIN PUMP HAD REJECTED BATTERIES AND HAD NO DELIVERY ALERTS ALSO OFTEN BUTTONS HAD TO BE PRESSED HARDER. CUSTOMER REPORTED LOUDER NOISE WHILE REWINDS AND COULD HEAR THE INSULIN BEING DOSED IN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9222759 ↗
• MalfunctionOct 22, 2019Moisture or Humidity Problem; Patient Device Interaction Problem; Moisture or Humidity Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOISTURE UNDER THE SCREEN, IMPAIRING VIEW OF THE SCREEN. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT LETTERING ON BUTTONS COMING OFF. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217683 ↗
• MalfunctionOct 18, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD ONLY HALF THE SCREEN VIEW-ABLE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS SITTING AT THE DINNING ROOM TABLE WHEN THE SCREEN WENT OUT AND THEN ONLY HALF THE SCREEN RETURNED. 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: No Consequences Or Impact To Patient

  MAUDE report 9206299 ↗
• MalfunctionOct 16, 2019Material Integrity Problem; Power Problem; Material Integrity Problem; Power Problem

  CUSTOMER¿S WIFE REPORTED VIA PHONE CALL THAT THE BATTERY CAP WAS STUCK ON INSULIN PUMP AND HAD FAILED BATTERY ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 370 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THE CONTACTS OF THE BATTERY CAP ARE DAMAGED. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9200554 ↗
• InjuryOct 16, 2019Device Alarm System; Mechanical Problem; Device Difficult to Program or Calibrate; Device Alarm System; Mechanical Problem; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE THAT INSULIN PUMP HAD BUTTON ERROR AND REWIND WAS LONGER. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9195713 ↗
• MalfunctionOct 15, 2019Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem

  CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE CUSTOMER'S INSULIN PUMP HAD A MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER'S MOTHER STATED THAT THE INSULIN PUMP HAD A RANDOM NO DELIVERY ALARM AND INSULIN PUMP WAS CRACKED. CUSTOMER'S MOTHER DECLINE TROUBLESHOOTING. CUSTOMER WAS ADVISED TO NOT USE THE INSULIN PUMP. THE PRODUCT WILL NOT RETURN FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9191072 ↗
• MalfunctionOct 9, 2019Display or Visual Feedback Problem; Mechanical Problem; Display or Visual Feedback Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD DIM BACK LIGHT. CUSTOMER DECLINED TO TROUBLESHOOT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9170242 ↗
• InjuryOct 3, 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 THEY WERE HOSPITALIZED DUE TO SEVERE CHEST PAIN AND HURTING DOWN BOTH OF HIS ARM, TROUBLE BREATHING, THROWING UP ON (B)(6) 2019. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 448 MG/DL AT THE TIME OF HOSPITALIZATION. THE CUSTOMER WAS ADMITTED TO HOSPITAL FOR OVERNIGHT BUT THE DOCTOR SAID THAT HE DID NOT HAVE DIABETIC KETOACIDOSIS. THE CUSTOMER TREATED WITH PAIN MEDICINES IN HOSPITAL. CUSTOMER WAS UNABLE TO COMPLETE CARELINK UPLOAD. THE CUSTOMER ALSO STATED THAT THE INFUSION SET WAS BENT UNDERNEATH HIS SKIN. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE VALUE AND BENT CANNULA. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Chest Pain; Hyperglycemia

  MAUDE report 9149529 ↗
• MalfunctionOct 2, 2019Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP NOT DOING ANYTHING AND REWOUND MESSAGE OCCURRED AFTER ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 116 MG/DL. CUSTOMER WAS ADVISED TO HOLD DOWN ACT BUTTON UNTIL THEY RECEIVE SECOND SERIES OF BEEPS AND NUMBERS WERE APPEAR ON THE DISPLAY. CUSTOMER STATED THAT THEY DID NOT RECEIVE SECOND SERIES OF BEEPS NOR DID NUMBERS WERE APPEARED ON THE SCREEN. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO REVERT TO BACKUP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9143825 ↗
• MalfunctionOct 1, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE LESS RESPONSIVE; HARDER TO PRESS AND SOMETIMES HAD TO PRESS THE BUTTONS TWICE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED SCRATCHES ON THE SCREEN. THE INSULIN PUMP HAD REJECTED NEW BATTERY AND HAD UNEXPLAINED NO DELIVERY ALERTS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9139004 ↗
• MalfunctionSep 30, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 180 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTED 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 AS PER HEALTH CARE PROFESSIONAL INSTRUCTION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9134417 ↗
• MalfunctionSep 27, 2019Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS STUCK TO REWIND PROCESS AFTER FILL TUBING. THE CUSTOMER¿S BLOOD GLUCOSE WAS 167 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER STATED THEY DID NOT RECEIVE SECOND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. 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 AS PER HEALTH CARE PROFESSIONAL INSTRUCTION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9128181 ↗
• MalfunctionSep 25, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 216 MG/DL. THE CUSTOMER STATED THAT THE DOWN BUTTON WAS NOT RESPONDING. 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 9114929 ↗
• MalfunctionSep 24, 2019Mechanical Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD RECEIVED FAILED BATTERY TEST AND HAD SCRATCHES ON THE SCREEN. THE CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9108138 ↗

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-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-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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