Paradigm® REAL-Time Revel™ MMT-723NAB (UDI 00613994743893)Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00613994743893), received between May 23, 2017 and Jun 23, 2023 — classified as 1 death, 16 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (24 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 87 reports, in the reporter's own words as published by the FDA.

• DeathJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2013. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WAS RETURNED FOR PRODUCT ANALYSIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17188536 ↗
• MalfunctionMar 31, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTON WAS NOT WORKING ANYMORE. 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 9902194 ↗
• MalfunctionFeb 17, 2020Display or Visual Feedback Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN WAS BROKEN AND CUSTOMER WAS NOT ABLE TO SEE FUNCTIONS ANYMORE. 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 9716300 ↗
• MalfunctionFeb 13, 2020Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP¿S BUTTONS WERE LESS RESPONSIVE AND NEED TO PRESS BUTTONS TWICE. IT WAS ALSO REPORTED THAT THE BATTERY LIFE OF INSULIN PUMP WAS DIMINISHED AND IT WAS ALSO REJECTING NEW BATTERY. 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 9704934 ↗
• MalfunctionJan 29, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER REPORTED INSULIN PUMP DID REQUIRE REWIND. CUSTOMER NOT ABLE TO COMPLETE REWIND. 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 9641342 ↗
• MalfunctionJan 29, 2020Failure to Cycle; Mechanical Problem; Detachment of Device or Device Component; Failure to Cycle; Mechanical Problem; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THE DEVICE WAS SQUIRTING INSULIN OUT DURING MANUAL PRIME PROCESS. INSULIN PUMP WAS STUCK IN REWIND PROCESS AND THE DRIVE SUPPORT CAP WAS STICKING OUT. DRIVE SUPPORT CAP WAS SLIGHTLY CAME OUT. 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 9640697 ↗
• MalfunctionNov 6, 2019Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP'S PLASTIC PIECE WAS CHIPPING AWAY NEAR THE RESERVOIR COMPARTMENT AND THEY WERE UNABLE TO TELL IF THE INSULIN PUMP WAS REWINDING. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9288835 ↗
• MalfunctionOct 31, 2019Failure to Cycle; Detachment of Device or Device Component; Priming Problem; Failure to Cycle; Detachment of Device or Device Component; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE CHANGING INFUSION SET AND A CODE CAME UP SAYING COMPROMISED FORCED SENSOR SYSTEM ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9258787 ↗
• MalfunctionOct 4, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM DURING THE REWIND. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED AND THEY HAD TO PUSH IT IN, BECAUSE IT POPS OUT, FOR IT TO PRIME. CUSTOMER STATED THAT THE STREAMING OF INSULIN DURING PRIMING, RATHER THAN DRIPPING OUT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9155121 ↗
• MalfunctionOct 3, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER STATED THAT INSULIN PUMP ALWAYS BUMPED HERE AND THERE BUT IT 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 BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9149712 ↗
• MalfunctionSep 24, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A MOTOR POSITION ENCODER ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 120 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS EXPOSED TO MAGNETIC RESONANCE IMAGING AND NOW GETTING ALARM. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9108570 ↗
• InjurySep 8, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPOGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 43 MG/DL AT THE TIME OF THE INCIDENT AND WAS TREATED WITH ORANGE JUICE. THE CUSTOMER¿S OTHER BLOOD GLUCOSE VALUE WAS 67 MG/DL. THE CUSTOMER WAS DRINKING ORANGE JUICE AND EATING FOOD TO TREAT LOW BLOOD GLUCOSE WHILE DOING THE TROUBLESHOOTING. THE CUSTOMER REPORTED THAT CUSTOMER STATED THAT THE INSULIN PUMP WAS CONTINUOUSLY DELIVERING INSULIN. THE CUSTOMER STATED PATIENT HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE FOR 3-4 MONTHS NOW. THE CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. THE CUSTOMER ALLEGED THAT THE INSULIN PUMP WAS OVER DELIVERING AS THE INSULIN PUMP KEPT ON DELIVERING INSULIN. THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL OR SLIGHTLY INDENTED. THE CUSTOMER WAS DISCONNECTED DURING THE REWIND OR PRIME SEQUENCE. THE CUSTOMER STATED THAT THEY HAD A BACK-UP PLAN AVAILABLE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8973427 ↗
• MalfunctionSep 2, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD BUTTON ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. 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: No Consequences Or Impact To Patient

  MAUDE report 8953227 ↗
• MalfunctionAug 29, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ABLE TO CLEAR IT OUT. CUSTOMER STATES THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8943701 ↗
• MalfunctionJul 29, 2019Premature Discharge of Battery; No Display/Image; Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Premature Discharge of Battery; No Display/Image; Device Difficult to Program or Calibrate; Moisture or Humidity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM AND INSULIN PUMP¿S BUTTON WERE UNRESPONSIVE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTS ON FIRST OCCURRENCE, THEY WERE ABLE TO CLEAR THE ALARM BUT NOT ABLE TO COMPLETE REWIND. CUSTOMER STATED THAT THEY GOT IN WATER AND THE INSULIN PUMP STOPPED WORK AND HAD UNEXPECTED RESTART ALARM BUT THE BUTTONS WERE NOT WORKING SO CUSTOMER CAN NOT CLEAR THE ALARM. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8836322 ↗
• MalfunctionJul 25, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE VALUE 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 8826318 ↗
• MalfunctionJul 24, 2019Premature Discharge of Battery; Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Premature Discharge of Battery; Device Difficult to Program or Calibrate; Moisture or Humidity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART AND A COLD RESET WAS PERFORMED AND THE BUTTONS WERE NOT WORKING. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 104 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT SHE WAS NOT ABLE TO CLEAR THE ALARM. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP WAS EXPOSED TO WATER. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8820685 ↗
• MalfunctionJul 16, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR WAS DAMAGED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 66 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE RESERVOIR WAS NOT ABLE TO LOCK WHEN INSERTED IN THE INSULIN PUMP. 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: No Consequences Or Impact To Patient

  MAUDE report 8792604 ↗
• MalfunctionJun 27, 2019Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NOT FUNCTIONING AND HAD MOTOR ERROR. CUSTOMER REPORTS THEY WERE UNABLE TO DESCRIBE THE POSSIBLE DAMAGE TO THE DRIVE SUPPORT CAP 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 DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8738721 ↗
• InjuryJun 10, 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 HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 500 MG/DL. THE CUSTOMER EXPERIENCED THE SYMPTOM SUCH AS NAUSEA ,HEADACHE. THE CUSTOMER WAS TREATED BY INTRAVENOUS BOLUS, ANTIBIOTIC AND INSULIN DRIPS. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE. 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 PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 8681697 ↗
• InjuryJun 4, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 500 MG/DL. CUSTOMER DID EXPERIENCED THE SYMPTOMS SUCH AS WEAK AND DIZZY LIGHTHEADED BAD HEADACHE. THE CUSTOMER WAS TREATED WITH INSULIN DRIP. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. CUSTOMER ALSO REPORTED THAT INSULIN PUMP WAS NOT WORKING AND INSULIN PUMP WAS NOT GIVING INSULIN. THE INSULIN PUMP WILL BE AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Headache; Hyperglycemia

  MAUDE report 8665740 ↗
• MalfunctionMay 22, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A PARTIAL DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATES THAT THEY DROPPED PUMP AND IT DAMAGED THE SCREEN. 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 NEED TO BE REPLACED. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8631272 ↗
• MalfunctionMay 17, 2019Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Connection Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Connection Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP¿S BUTTONS WERE HARD TO PRESS AND HAVE TO PRESSED FOR MORE THAN ONE TIME. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT THE BUTTONS WERE WORN OUT OR STICKING. THE CUSTOMER MENTIONED THAT THE INSULIN PUMP HAD CRACKS, FRACTURES, CHIPS OR BREAKAGES. THE INSULIN PUMP HAD LINES, SPOTS, WARPING, RAIN BOWING, CLOUDINESS OR STARCHES ON THE SCREEN. THE RESERVOIR WAS NOT SECURE IN THE INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8618721 ↗
• MalfunctionMay 8, 2019Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR AND ALSO HAD MOTOR POSITION ENCODED ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 160 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THE RESERVOIR COMPARTMENT WAS CRACK AND RESERVOIR WAS ABLE TO LOCK IN PLACED. CUSTOMER ALSO STATED THE DRIVE SUPPORT CAP WAS APPEARS NORMAL. TROUBLESHOOTING WAS PERFORMED. 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 PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8589673 ↗
• MalfunctionMay 7, 2019Premature Discharge of Battery; Power Problem; Patient Device Interaction Problem; Premature Discharge of Battery; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD RECEIVED UNEXPECTED RESTART AND A COLD RESET WAS PERFORMED. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD RECEIVED BATTERY OUT LIMIT ALARM, FAILED BATTERY TEST ALARM AND CRACK AT TOP BATTERY COMPARTMENT. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER REPORTED THAT THE INSULIN PUMP DID NOT REQUIRE REWIND. CUSTOMER STATED THAT THE CALLING BACK AFTER COMPLETING INSULIN PUMP ERROR ALARM TROUBLESHOOTING AND NOT RECEIVING ANOTHER INSULIN PUMP ERROR ALARM AFTER A BATTERY CHANGE. CUSTOMER TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THAT THE ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. CUSTOMER WAS ADVISED TO MONITOR THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8585627 ↗

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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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-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-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