Paradigm® REAL-Time Revel™ MMT-523LNAH (UDI 00643169151284)Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00643169151284), received between Jun 8, 2017 and Jan 17, 2020 — classified as 1 death, 28 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (8 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 61 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2020Adverse 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 SOCIAL MEDIA THAT THEY EXPERIENCED DIABETIC KETOACIDOSIS DUE TO INSULIN PUMP ISSUE FOR 4 TIMES. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THEY REPLACED THE INSULIN PUMP FOR SAME 4 TIMES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9599873 ↗
• MalfunctionNov 22, 2019Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem

  IT WAS REPORTED THAT THERE WAS LIQUID IN THE CHAMBER. THE BUTTONS WERE HAVING ERRORS AND WERE STICKY. SHE WAS HAVING PROBLEMS WITH THE ESCAPE BUTTON. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. THE DEVICE WAS NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9360528 ↗
• MalfunctionNov 13, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 101 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED TIME ADVANCED. 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 NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9319375 ↗
• MalfunctionAug 29, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT INSULIN PUMP HAD BUTTON ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE VALUE WAS 80 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTED THAT THE TIME WAS ADVANCING. 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 8945083 ↗
• MalfunctionJul 26, 2019Mechanical Problem; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 112 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER REPORTED THAT THEY WERE ABLE TO REWIND THE INSULIN PUMP. THE CUSTOMER WAS ADVISED TO REPLACE AND 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 8829991 ↗
• MalfunctionJul 5, 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. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTS THAT THE UP AND DOWN ARROW KEYS ARE INTERMITTENTLY WORKING. CUSTOMER HAD TO PRESS DOWN HARD FOR THEM TO WORK. CUSTOMER STATES THAT IT WAS MORE THE UP ARROW KEY. 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 8763530 ↗
• MalfunctionMay 29, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  IT WAS REPORTED THAT INSULIN PUMP ACT AND ESC BUTTON HAD TO PUSH REALLY HARD TO WORK. THE CUSTOMER'S BLOOD GLUCOSE WAS 165 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT AREA OF THE RESERVOIR WAS BROKEN. THE CUSTOMER REPORTS THAT RESERVOIR WAS ABLE TO LOCKED INTO THE PLACE. 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 8652628 ↗
• InjuryMay 23, 2019Premature Discharge of Battery; No Apparent Adverse Event; Unexpected Shutdown; Priming Problem; Premature Discharge of Battery; No Apparent Adverse Event; Unexpected Shutdown; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. THE CUSTOMER¿S BLOOD GLUCOSE WAS 150 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATES THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER ALSO REPORT THAT THE INSULIN PUMP HAD MULTIPLE PUMP ERROR AND CUSTOMER WAS ABLE TO CLEAR THE ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 8635078 ↗
• MalfunctionApr 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INSULIN PUMP HAD DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8490117 ↗
• MalfunctionApr 5, 2019Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS UNABLE 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 8486421 ↗
• InjuryMar 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME. THE CAUSE OF DEATH WAS DIABETIC KETOACIDOSIS. THE CALLER STATED THAT THE CUSTOMER HAD NO OTHER ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS OVER 600 MG/DL AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE INSULIN PUMP HAD BEEN DISCONNECTED LESS THAN 24 HOURS PRIOR TO PASSING. THE CUSTOMER WAS SICK AND HAD REVERTED TO MANUAL INJECTIONS. THE CUSTOMER WAS NOT USING SENSORS. THE CUSTOMER WAS DEAD ON ARRIVAL AT THE HOSPITAL. THE CUSTOMER HAD MULTIPLE DIABETIC KETOACIDOSIS INCIDENTS BEFORE PASSING. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS AS THEY NO LONER HAD IT.

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

  MAUDE report 8393352 ↗
• MalfunctionMar 5, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. THE INSULIN PUMP WAS EXPOSED TO MOISTURE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8389788 ↗
• MalfunctionFeb 21, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD LOCKED UP AND BECAME UNRESPONSIVE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8356816 ↗
• MalfunctionDec 13, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 180 MG/DL,200 MG/DL. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE AND NOTICED THE RESERVOIR LOCK IN PLACE. ADVISED THE PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE 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 8159193 ↗
• MalfunctionOct 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 174 MG/DL. 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. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8012366 ↗
• MalfunctionOct 18, 2018Power Problem; Power Problem

  THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD FAILED BATTERY TEST ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT INSULIN PUMP REJECTED THE NEW BATTERY AND IT GIVES THE NO DELIVERY ALARM. THE CUSTOMER STATED THAT INSULIN PUMP HAD COSMETIC DAMAGE. THE CUSTOMER REPORTS CRACK WHERE THE BATTERY CAP AND THE RESERVOIR AND BATTERY CAP WAS NOT STAY PROPERLY. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7977473 ↗
• InjuryOct 4, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL 400 MG/DL. THE CUSTOMER STATED THAT RESERVOIR O RING MISSING. THE RESERVOIR WAS UNABLE TO LOCK IN PLACE. TROUBLESHOOTING WAS NOT PERFORMED FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7936764 ↗
• InjurySep 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED A HIGH BLOOD GLUCOSE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 500 MG/DL. CUSTOMER VOMITED AND TREATED THEIR HIGH BLOOD GLUCOSE LEVELS VIA INSULIN PUMP AND MANUAL INJECTION. CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL WAS 170 MG/DL. CUSTOMER PERFORMED AND PASSED THE SELF TEST AND THE DEVICE PERFORMED AS DESIGNED. CUSTOMER WAS ADVISED TO CHANGE OUT THEIR ENTIRE INFUSION SET, RESERVOIR, INSULIN AND TREAT THEIR HIGH BLOOD GLUCOSE PER HEALTHCARE PROVIDER¿S INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7917778 ↗
• MalfunctionSep 25, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 180 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED 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. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7904800 ↗
• InjurySep 9, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE AS WELL AS INSULIN PUMP HAD A OVER DELIVERING ALARM. BLOOD GLUCOSE READING WAS 25 MG/DL AT THE TIME OF INCIDENT. CURRENT BLOOD GLUCOSE READING WAS 98 MG/DL. CUSTOMER TREATED THEIR BLOOD GLUCOSE WITH FOOD AND GLUCOSE TABLETS. THE CUSTOMER ALLEGED THE PUMP WAS OVER-DELIVERING INSULIN. TROUBLESHOOTING DID NOT FIND ANY ISSUES WITH THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7858884 ↗
• MalfunctionAug 28, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER'S FATHER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED BUTTON ERROR AND COSMETIC DAMAGE. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP RESERVOIR CHIPS AWAY EVERY TIME THEY TRY AND LOCK IT IN PLACE. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE CUSTOMER'S INSULIN PUMP IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7824828 ↗
• InjuryAug 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS ON (B)(6) 2018. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 486 MG/DL AT THE TIME OF HOSPITALIZATION. CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 525 MG/DL. THE PRODUCT WILL NOT RETURN FOR THE ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7808218 ↗
• InjuryAug 14, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS 544MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP ACT BUTTON HAS TO BE PRESSED MULTIPLE TIMES TO WORK. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS NOT EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7780111 ↗
• MalfunctionJul 19, 2018Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AN UNEXPECTED RESTART AND EXTERNAL RAM CRC ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 96 MG/DL. THE CUSTOMER WAS ASSISTED WITH THE TROUBLESHOOTING. THE INSULIN PUMP WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7702930 ↗
• MalfunctionJun 18, 2018No Display/Image; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A FULL BLACK SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT ACCEPTING BATTERIES IN THE INSULIN PUMP AFTER A CHANGE, THE SCREEN WAS TURNED BLACK AFTER THE INSERTION OF A NEW BATTERY. THE TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER REPORTED THAT THEY HAD PERFORMED THE SELF TEST AND THE TEST WAS PASSED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7608749 ↗

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-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-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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