Paradigm® REAL-Time Revel™ MMT-523NAH (UDI 00643169446397)Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00643169446397), received between Jun 28, 2017 and Jul 1, 2020 — classified as 17 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (12 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR WAS CHIPPED, REWOUND MORE THAN ONCE AND WAS SLOWER DURING 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 10217011 ↗
• MalfunctionJun 5, 2020Device Alarm System; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Device Alarm System; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP WAS DELIVERING NOT ENOUGH INSULIN. CUSTOMER STATED THAT SOMETIMES SHE WAS GETTING TOO MUCH INSULIN AND SOMETIMES NOT AT ALL. CUSTOMER REPORTED THAT SHE HAD NOT BEEN IN THE HOSPITAL OF INSULIN PUMP RELATED ISSUES YET BUT, THAT CUSTOMER WAS WORRIED THAT IF IT WAS NOT TAKEN CARE OF SOON THAT SHE WILL BE IN HOSPITAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10121947 ↗
• MalfunctionApr 9, 2020Premature Discharge of Battery; No Display/Image; Patient Device Interaction Problem; Premature Discharge of Battery; No Display/Image; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP DISPLAY WENT BLANK. CUSTOMER STATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARMS. CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR ALARM. CUSTOMER STATED THAT THE PIECE ON BATTERY COMPARTMENT WAS BROKEN. 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 9942719 ↗
• MalfunctionApr 6, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT ON THE REWIND PROCESS, THE PISTON WAS NOT GOING ALL THE WAY DOWN AND RESERVOIR WAS NOT COMPLETELY FIT IN TO THE COMPARTMENT. CUSTOMER DID SELF TEST AND IT WAS PASSED. 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 9927987 ↗
• MalfunctionDec 4, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE LESS SENSITIVE AND HARDER TO PUSH. 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 9414484 ↗
• InjuryNov 5, 2019Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS EXPERIENCED HYPERGLYCEMIA. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 450 MG/DL AT THE TIME OF CALL. CUSTOMER WAS TREATED WITH BOLUS. CUSTOMER ALSO REPORTED THAT SHE DID NOT FEEL THAT INSULIN PUMP WAS WORKING BECAUSE SHE RECEIVED A NO DELIVERY ALARM AND INSULIN EXITED THE TUBING. TROUBLESHOOTING WAS PERFORMED FOR NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9278363 ↗
• MalfunctionSep 11, 2019Mechanical Problem; Obstruction of Flow; Battery Problem; Mechanical Problem; Obstruction of Flow; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE UNKNOWN. CUSTOMER ALSO STATED THAT BATTERY LIFE WAS DIMINISHED ALSO THE INSULIN PUMP RECEIVE UNEXPLAINED AND RANDOM NO DELIVERY ALARMS. CUSTOMER STATED THAT INSULIN PUMP LOST THE SETTING DURING THE BATTERY CHANGE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8987826 ↗
• MalfunctionJul 23, 2019Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS LOUDER DURING REWINDING. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE MOTOR SOUNDS LABORED AND THEY HAD UNEXPLAINED NO DELIVERY ALARMS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8814846 ↗
• MalfunctionApr 1, 2019Premature Discharge of Battery; Patient Device Interaction Problem; Unexpected Shutdown; Premature Discharge of Battery; Patient Device Interaction Problem; Unexpected Shutdown

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATES THEY WERE ABLE TO CLEAR ALARM AND ABLE TO REWIND 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 8468658 ↗
• MalfunctionMar 7, 2019No Display/Image; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; No Display/Image; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD A UNRESPONSIVE BUTTONS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD RANDOM NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8398722 ↗
• MalfunctionFeb 22, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE THAT INSULIN PUMP HAD MOTOR ERROR AND NO DELIVERY ALERTS. 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 8360847 ↗
• MalfunctionFeb 15, 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 UNKNOWN. THE CUSTOMER REPORTED THAT THE ARROW UP AND THE NUMBERS DO NOT STOP UNTIL 600 AND THEN GOES BACK DOWN TO THE STARTING NUMBER, DON'T LET THEM TO ENTER MANUALLY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8342266 ↗
• MalfunctionNov 26, 2018Failure to Cycle; Failure to Cycle

  THE CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 217 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER ALSO REPORTED THAT THEY WERE NOT ABLE TO CLEAR THE ALARM AND INSULIN PUMP DID REQUIRE REWIND. CUSTOMER ABLE TO COMPLETE REWIND. CUSTOMER WAS DECLINED TO TROUBLESHOOT. 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: Hyperglycemia

  MAUDE report 8100778 ↗
• MalfunctionNov 18, 2018No 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 UNKNOWN. 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 NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8082616 ↗
• InjuryNov 15, 2018Adverse 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. THE CUSTOMER'S BLOOD GLUCOSE WHEN ADMITTED TO HOSPITAL WAS 500 MG/DL. THE CUSTOMER ALSO REPORT THE BLOOD GLUCOSE WAS 200 MG/DL. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING SYMPTOMS AND TREATMENT OF HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8076557 ↗
• InjuryNov 14, 2018Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Power Problem; Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 400 AND 489 MG/DL. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND PARTIAL DISPLAY. THE CUSTOMER DID NOT PROVIDE ANY SYMPTOMS REGARDING HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED FOR THE HIGH BLOOD GLUCOSE WITH MANUAL INJECTIONS. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8068268 ↗
• MalfunctionOct 26, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP REJECTING THE NEW BATTERIES, ESCAPE BUTTON WAS HARDER TO PRESS AS WELL AS RANDOM NO DELIVERY ALARMS. 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 8008456 ↗
• MalfunctionOct 8, 2018Connection Problem; Connection Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR UNABLE TO LOCK. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE INSULIN PUMP HAD CRACKED IN RESERVOIR COMPARTMENT OPENING. CUSTOMER STATED THAT THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP, IT JUST FALLS OUT SOMETIMES. 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 7942064 ↗
• InjurySep 19, 2018No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS OVER 600 MG/DL. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD FROZEN DISPLAY AS WELL AS INSULIN PUMP ALARMED AFTER BATTERY CHANGED. CUSTOMER ALSO REPORTED THAT THEY WERE UNABLE TO CLEAR THE ALARM. CUSTOMER STATED THAT AN ALARM OCCURRED DURING THAT TIME THE BUTTONS STOPPED. SCREEN WAS NOT BLANK AFTER INSERTING NEW BATTERY. TROUBLESHOOT WAS PERFORMED. CUSTOMER ADVISED TO INSULIN PUMP WILL NEED TO BE REPLACED AND REVERT TO BACK UP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7892388 ↗
• MalfunctionSep 7, 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 PATIENT¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7854208 ↗
• MalfunctionSep 6, 2018Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND PRIME FILL ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 220 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 STICKING OUT. 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 7849555 ↗
• MalfunctionAug 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED NO DELIVERY AND LOW BATTERY ALERT GREATER THAN A WEEK. CUSTOMER BLOOD GLUCOSE READING WAS UNKNOWN. CUSTOMER DECLINED TROUBLESHOOTING. CUSTOMER TRIED ALL THE REMEDIES BUT THE REOCCURRED. INSULIN PUMP WILL BE RETURNING FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7766549 ↗
• MalfunctionAug 8, 2018Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SEVERAL ISSUES. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THE INSULIN PUMP BATTERY LIFE DOES NOT LAST LONG, BUTTONS WERE HARD TO PUSH, INSULIN SQUIRTS OUT, HAD A NO DELIVERY AND FAILED BATTERY TEST ALARMS. CUSTOMER DECLINED TROUBLESHOOTING. INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7765842 ↗
• InjuryAug 2, 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 UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP DOWN BUTTON WAS UNRESPONSIVE. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP WAS SQUIRTING OUT DURING MANUAL PRIME PROCESS. CUSTOMER HAD A HIGH BLOOD GLUCOSE OF IN THE 400 MG/DL TO 500 MG/DL AND TREATED MANUAL INJECTION AND INSULIN PUMP. CUSTOMER DECLINED HIGH BLOOD GLUCOSE TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7743840 ↗
• InjuryJul 25, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A BUTTON ERROR ALARM AND HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. CUSTOMER ALSO REPORTED DAMAGE TO THE INSULIN PUMP BATTERY AND RESERVOIR COMPARTMENT. CUSTOMER HAD A HIGH BLOOD GLUCOSE OF IN THE 300 MG/DL TO 400 MG/DL AND TREATED. NO HIGH BLOOD GLUCOSE TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7718163 ↗

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-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-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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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