Paradigm® REAL-Time Revel™ MMT-723RNAH (UDI 00643169476578)Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00643169476578), received between Aug 11, 2017 and Feb 14, 2022 — classified as 1 death, 19 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (11 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2022Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR THE ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13530467 ↗
• MalfunctionDec 30, 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 VALUE WAS 253 MG/DL. CUSTOMER REPORTED THAT INSULIN PUMP WAS STUCK ON THE LOW RESERVOIR SCREEN AND SHE CANNOT GET THE INSULIN PUMP BACK TO THE MAIN MENU TO REWIND IT. CUSTOMER STATED THE TIME CLOCK ADVANCES. 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 9530134 ↗
• MalfunctionDec 19, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS OF THE INSULIN PUMP WERE HIT MULTIPLE TIMES AND HARDER FOR THEM TO ACTIVATE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT THE BOTTOM OF THE CASING THERE WAS DISCOLORATION AND LOOKS BURNT, CRACK IN THE CASING AROUND THE SCREEN AND RANDOM NO DELIVERY ALARMS. CUSTOMER STATED THAT ONE TIME REWIND SEEMED SLOWER THAN NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9493903 ↗
• MalfunctionNov 8, 2019Device Alarm System; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Device Alarm System; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTONS NEED TO BE PRESSED A COUPLE TIMES FOR THEM TO RESPOND. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD THREADS IN BATTERY PORT ARE WORN OUT, BATTERIES LASTING LESS THAN A WEEK, SCRATCHES ON THE SCREEN, LOUD DURING REWIND, FREQUENT NO INSULIN DELIVERY ALARMS WITHOUT AN EXPLANATION, REWIND THE INSULIN PUMP MORE THAN ONCE PER RESERVOIR CHANGE AND SOMETIMES DID NOT ALERT WHEN BATTERY AND RESERVOIR WAS LOW. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9294231 ↗
• MalfunctionNov 5, 2019Device Alarm System; Premature Discharge of Battery; Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Material Integrity Problem; Power Problem; Patient Device Interaction Problem; Device Alarm System; Premature Discharge of Battery; Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Material Integrity Problem; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP MOTOR WAS SLOWER AND SLUGGISH. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD FAILED BATTERY TEST SEVERAL TIMES, DOES NOT GIVE LOW BATTERY ALERT, SCREEN WAS CLOUDY, BACKLIGHT WAS NOT BRIGHT ANYMORE, HAD RANDOM NO DELIVERY ALARMS, AND BATTERY CAP THREADING WAS CRACKED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9281799 ↗
• MalfunctionOct 18, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ARE NOT FUNCTIONING CORRECTLY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE ALL ALARMS ARE NOT RESPONDING. CUSTOMER REPORTED THAT THE BUTTONS ARE HARD TO PUSH DOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9206880 ↗
• MalfunctionOct 4, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP'S ACT BUTTON HARD TO PRESSED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9155086 ↗
• MalfunctionOct 3, 2019Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Material Integrity Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Material Integrity Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS OF INSULIN PUMP WAS STICKY AND HARD TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THERE WAS CRACK AT NEAR BATTERY CAP AND ON SIDE OF CASING AND ALSO HAD TO TROUBLE FOR SCREWING IN BATTERY CAP. THE CUSTOMER STATED THAT THERE WAS DIMMED BACK LIGHT AND GRINDING WHILE REWINDING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9151537 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF INCIDENT AND OTHER BLOOD GLUCOSE WAS 466 MG/DL. THE CUSTOMER DECLINE TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE CUSTOMER ALSO STATED THAT CANNULA WAS BENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9140275 ↗
• MalfunctionAug 29, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTONS ARE HARD TO PRESS. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP WAS CRACKED WHERE THE BATTERY GOES IN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8944129 ↗
• MalfunctionAug 23, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR HAD DAMAGED. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 123 MG/DL. THE CUSTOMER STATED THAT THE DAMAGED TO THE RESERVOIR TOP WAS BROKEN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8924295 ↗
• MalfunctionAug 22, 2019Mechanical Problem; Obstruction of Flow; Battery Problem; Power Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MOTOR ERROR OR REWIND ERROR. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT BATTERIES LASTED FOR 6 DAYS, INSULIN PUMP HAS REJECTED NEW BATTERIES AND HAD UNEXPLAINED NO DELIVERY ALARMS. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8919354 ↗
• MalfunctionAug 20, 2019Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE ALL BUTTONS WERE HARD TO USE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD FOGGY SCREEN. CUSTOMER ALSO STATED THAT THERE WAS FLUID UNDER THE LCD DISPLAY. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF 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 8909206 ↗
• MalfunctionJun 18, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP WAS OVER DELIVERING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 156 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS AT UNKNOWN. CUSTOMER WAS TREATED WITH FOOD. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. CUSTOMER WAS ALLEGING FOR OVER DELIVERING BECAUSE CUSTOMER WENT LOW AFTER CORRECTION. THE INSULIN PUMP WILL BE AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8706730 ↗
• MalfunctionJun 3, 2019Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Device Difficult to Program or Calibrate; Visual Prompts will not Clear

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ANOMALY. THE CUSTOMER'S BLOOD GLUCOSE WAS 388 MG/DL. THE CUSTOMER STATED THE BUTTONS WAS NOT RESPONDING. THE TROUBLESHOOTING WAS PERFORMED FOR BUTTON ERROR. THE CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND FOUND THAT IT WAS. THE CUSTOMER WAS ADVISED DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACKUP PLAN AND THE INSULIN PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8661601 ↗
• MalfunctionApr 27, 2019No Display/Image; Moisture or Humidity Problem; No Display/Image; Moisture or Humidity Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP DISPLAY WENT BLANK IMMEDIATELY AFTER PUMP EXPOSURE TO MOISTURE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 113 MG/DL. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD VIBRATING WITHOUT AN ALARM OR ALERT AND CONSTANT TONE WAS OCCURRING. 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 8559303 ↗
• InjuryApr 18, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED THE HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 300, 400 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE CUSTOMER STATED THAT THE ISSUE WAS RESOLVED BY CHANGING COMPLETE SET. THE CUSTOMER WAS NO LONGER WEARING INSULIN PUMP BECAUSE HER BLOOD GLUCOSE WAS TOO HIGH AND WAS MAKING HER SICK. THE TROUBLESHOOTING WAS NOT PERFORMED FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8526259 ↗
• MalfunctionApr 18, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 171 MG/DL AT THE TIME OF THE INCIDENT. THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. THE CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. 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 8525967 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS ON UNKNOWN DATE WITH BLOOD GLUCOSE OF UNKNOWN. CUSTOMER TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8435338 ↗
• MalfunctionMar 15, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 366 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT WORKING PROPERLY AND INCURRED A MOTOR ERROR. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE PUMP REWIND. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WAS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8423948 ↗
• MalfunctionMar 14, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR DURING BOLUS. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTS THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER STATED THAT THE INSULIN PUMP DID NOT EXPOSED TO HIGH MAGNETIC FIELD. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED THAT THE INSULIN ALARM HISTORY CONTAINS MORE THAN ONE MOTOR ERROR ALARM WITHIN THE LAST 30 DAYS. 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: Hyperglycemia

  MAUDE report 8419336 ↗
• MalfunctionMar 11, 2019Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD TROUBLE DURING FILLING THE INSULIN PUMP. THE CUSTOMER¿S BLOOD GLUCOSE WAS 59 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATES THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER STATES THE DRIVE SUPPORT CAP APPEARS NORMAL OR RECESSED. CUSTOMER STATES THEY DID NOT RECEIVE SECOND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. 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 8407870 ↗
• InjuryFeb 12, 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 CALL THAT THEY WERE HOSPITALIZED DUE TO HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 300 MG/DL, 400 MG/DL, 350 MG/DL, 242 MG/DL AND 1200 MG/DL AND TREATED WITH INSULIN PUMP. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOT. CUSTOMER STATES THAT INSULIN PUMP HAD NO LEAKS AND NO BENT CANNULAS. CUSTOMER STATES THAT THE INSULIN PUMP HAD NO DELIVERY ALARM, PAST EVENT. CUSTOMER REPORTS ALARM DID NOT OCCUR DURING MANUAL PRIME. CUSTOMER REPORTS EVENT WAS RESOLVED BY CHANGING COMPLETE SET. CUSTOMER STATES THEY WERE NOT COMFORTABLE WITH INSULIN PUMP. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Discomfort; Hyperglycemia

  MAUDE report 8331256 ↗
• InjuryFeb 5, 2019Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 1200 MG/DL. CUSTOMER'S OTHER BLOOD GLUCOSE LEVEL WAS 350 MG/DL. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING SYMPTOMS OF THEIR HIGH BLOOD GLUCOSE EPISODES. CUSTOMER WAS TREATED WITH EMERGENCY MEDICAL SERVICE, INTENSIVE CARE UNIT AND INTRAVENOUS INSULIN DRIP. CUSTOMER STATED THAT THE INSULIN PUMP HAD RECEIVED NO DELIVERY ALARMS. CUSTOMER CONTINUE WITH TROUBLESHOOT FOR NO DELIVERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 8305508 ↗
• InjurySep 24, 2018Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS AND WAS ABLE TO COMPLETE THE REWIND PROCESS. DISPLACEMENT TEST WAS PERFORMED AND PASSED. CUSTOMER ALSO REPORTED A HIGH BLOOD GLUCOSE OF 424 MG/DL AND NO FORM OF TREATMENT WAS REPORTED. NO HIGH BLOOD GLUCOSE TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED TO MONITOR AND CALL BACK FOR FURTHER ASSISTANCE. THE INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7900959 ↗

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-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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