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Paradigm® REAL-Time Revel™ MMT-523NAL (UDI 00643169446403)Recalls & reported problems

Medtronic Minimed, Inc. · PUMP MMT-523NAL PRDGM V2.5B CL US PR · Class 3

All models of Paradigm REAL-Time Revel (180)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This is a Medtronic MiniMed Paradigm REAL-Time Revel insulin pump, an implanted-in-body continuous glucose monitor and insulin delivery device. The 55 reports mostly describe the pump showing wrong messages, blank or frozen screens, unexpected restarts, error alarms and buttons that stop responding, along with blocked infusion sites and parts breaking. Twenty reports describe injuries, mostly high blood sugar, and there are no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
55
Deaths reported
0
Injuries reported
20
Recalls naming it
0

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00643169446403), received between Jun 5, 2017 and Oct 9, 2019 — classified as 20 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (13 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

Device problems

  • Device Displays Incorrect Message13
  • Adverse Event Without Identified Device or Use Problem6
  • Obstruction of Flow4
  • Break3
  • Crack3
  • Device Difficult to Program or Calibrate3
  • Device Operates Differently Than Expected3
  • No Display/Image3

Patient problems

  • No Consequences Or Impact To Patient34
  • Hyperglycemia18
  • Hypoglycemia5
  • Loss of consciousness1

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 9, 2019No Display/Image; No Display/Image

    CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP WAS NOT WORKING. CUSTOMER¿S BLOOD GLUCOSE WAS 170 MG/DL. CUSTOMER STATED THAT INSULIN PUMP HAD BLANK SCREEN AND INSULIN PUMP¿S DISPLAY DID NOT RETURN EVEN AFTER TROUBLESHOOTING. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF INSULIN PUMP AND REVERT TO BACK UP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9171200 ↗
  • InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CUSTOMER'S DOCTOR REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS ADMITTED TO HOSPITAL AND WAS FOUND UNCONSCIOUS ON THE GROUND. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS HIGH OF 300 MG/DL. THE CUSTOMER'S DOCTOR WANTED TO CHECK IF IT WAS THE INSULIN PUMP THAT HAD CAUSED HER HIGH BLOOD GLUCOSE INCIDENT. THE CUSTOMER FELT OK TO TROUBLESHOOTING HIGH BLOOD GLUCOSE LEVEL. CUSTOMER'S DOCTOR WHO CALLED FOR CUSTOMER WOULD SPEAK TO FAMILY MEMBERS. CUSTOMER'S DOCTOR WAS TOLD THAT THERE WERE AREA A NUMBER OF POSSIBLE REASONS WHICH COULD CAUSE HIGH BLOOD GLUCOSE. CUSTOMER'S DOCTOR SAID THAT ONE OF CUSTOMER'S CHILDREN WAS A DOCTOR HERSELF AND SAID THAT THE CUSTOMER'S BLOOD GLUCOSE WAS SOMEWHAT LOW THRESHOLD AND THAT SHE SHOULD BE JUST AT 90 TO 140 MG/DL, OTHERWISE SHE WOULD BE DISORIENTED. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia; Loss of consciousness

    MAUDE report 9076379 ↗
  • InjurySep 16, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL, 183 MG/DL AND 387 MG/DL. THE CUSTOMER DID NOT MENTION ANY TREATMENT RELATED TO HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER DID NOT MENTION ANY SYMPTOM RELATED TO HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD MOTOR ERROR. THEY STATED THAT THEY WERE ABLE TO CLEAR THE ALARM AND REWIND THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM WHICH WAS RESOLVED BY COMPLETE SET CHANGE. THEY STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. 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: Hyperglycemia

    MAUDE report 9070457 ↗
  • MalfunctionJul 25, 2019Device Difficult to Program or Calibrate; Insufficient Device Problem Information; Device Difficult to Program or Calibrate; Insufficient Device Problem Information

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD CONSTANTS ALERTS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THEY NOT ABLE TO CONNECT QUICKSET AT QUICK RELEASE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8826973 ↗
  • MalfunctionMay 2, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 120 MG/DL. BUTTONS WERE NOT RESPONDING. THE TIME CLOCK ADVANCES. CUSTOMER WAS 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 DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8571942 ↗
  • MalfunctionMay 1, 2019Premature Discharge of Battery; Unexpected Shutdown; Premature Discharge of Battery; Unexpected Shutdown

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED UNEXPECTED RESTART AND EXTERNAL RAM CRC ERROR. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM AND INSULIN PUMP WAS ABLE TO COMPLETE REWIND. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER STATED THAT THE INSULIN PUMP RECEIVED ANOTHER UNEXPECTED RESTART ALARM AFTER BATTERY CHANGE. 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 BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8568281 ↗
  • MalfunctionApr 8, 2019Premature Discharge of Battery; Premature Discharge of Battery

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE TROUBLESHOOTING WAS PERFORMED. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM. THE CUSTOMER WAS ABLE TO COMPLETE REWIND. THE ALARM WAS OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. THE CUSTOMER HAS NOT EXPERIENCED MULTIPLE UNEXPECTED RESTART ALARMS AFTER BATTERY CHANGE. THE CUSTOMER WAS ADVISED TO MONITOR THE PUMP AND CALL IF ISSUES RECUR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8490417 ↗
  • InjuryDec 13, 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 EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 570 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN PUMP AS WELL AS MANUAL INJECTIONS FOR HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER HAD SAUSAGE, BACON AND A PIECE OF TOAST FOR BREAKFAST. THE CUSTOMER DECLINED THE TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVELS. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8159259 ↗
  • MalfunctionDec 10, 2018No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY AND BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 223 MG/DL. THE CUSTOMER REPORTED THAT INSULIN PUMP WHILE TRYING TO BOLUS THEN WENT BLANK. IT WAS REPORTED THAT THE BUTTON CONTINUES TO SCROLL WITHOUT INPUT. THE CUSTOMER REPORTED THAT THE TIME CLOCK WAS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8146531 ↗
  • MalfunctionOct 17, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

    IT WAS REPORTED VIA PHONE CALL, THAT THE INSULIN PUMP HAS A CRACK AND IS HALFWAY BROKEN OFF OF THE RESERVOIR LIP. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7972733 ↗
  • MalfunctionOct 15, 2018Moisture or Humidity Problem; Moisture or Humidity Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART THE CUSTOMER ALSO REPORT THAT THE PUMP HAD A BLACK SCREEN. THE CUSTOMER ALSO REPORT THERE WAS FLUID UNDER THE LCD DISPLAY. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER NOT ABLE TO COMPLETE REWIND. THE CUSTOMER WAS ADVICE CUSTOMER THE PUMP WILL NEED TO BE REPLACED. ADVICE CUSTOMER TO REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTION. INSULIN PUMP WILL BE RETURN FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7964500 ↗
  • MalfunctionOct 11, 2018Priming Problem; Priming Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN WAS SHOT OUT DURING PRIME. 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 7954979 ↗
  • MalfunctionOct 9, 2018Mechanical Problem; Mechanical Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN WAS SQUIRTED OUT DURING MANUAL PRIME. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD REJECTED BATTERY AND REWINDS LOUDER AND SLOWER. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7948312 ↗
  • MalfunctionSep 21, 2018Obstruction of Flow; Obstruction of Flow

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD DAMAGE ON THE INSULIN PUMP SCREEN. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS NOT REPORTED. THE CUSTOMER STATES THAT THE INSULIN PUMP SCREEN HAD SCRATCHES. THE CUSTOMER STATED THAT THE SCREEN WAS DIFFICULT TO READ. THE CUSTOMER ALSO REPORTED AN UNRESPONSIVE KEYPAD. TROUBLESHOOTING WAS NOT PROVIDED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7899552 ↗
  • InjuryAug 20, 2018No Apparent Adverse Event; No Apparent Adverse Event

    CUSTOMER REPORTED VIA PHONE CALL ON (B)(6) 2018 THAT THE INFUSION SET HAD A BENT CANNULA. CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 48MG/DL. PRODUCT IS NOT EXPECTED TO RETURN.

    Patient problems: Hyperglycemia; Hypoglycemia

    MAUDE report 7796658 ↗
  • MalfunctionAug 13, 2018Priming Problem; Priming Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD REJECTED BRAND NEW BATTERY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS DECLINED. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7776199 ↗
  • MalfunctionAug 7, 2018Power Problem; Power Problem

    THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THE CUSTOMER INSULIN PUMP HAD A KEYPAD ANOMALY AND FAILED BATTERY TEST ALARM . THE CUSTOMER¿S BLOOD GLUCOSE WAS 111 MG/DL AT THE TIME OF INCIDENT. CUSTOMER¿S PARENT STATED THAT THE INSULIN PUMP BUTTONS WERE UNRESPONSIVE AFTER EXPOSURE TO MOISTURE AD UNABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED AND UNABLE TO CONFIRM IF THE TIME IS ADVANCING. THE CUSTOMER¿S PARENT WAS ADVISED TO HAVE CUSTOMER 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: No Consequences Or Impact To Patient

    MAUDE report 7755744 ↗
  • MalfunctionAug 6, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD REWIND ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7754887 ↗
  • InjuryJul 19, 2018Obstruction of Flow; Obstruction of Flow

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 400 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER WILL NOT BE RETURNED DEVICE FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 7702836 ↗
  • MalfunctionJul 13, 2018Failure to Cycle; Failure to Cycle

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AS WELL AS CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 82 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE INSULIN WAS "SQUIRTING OUT" DURING THE MANUAL PRIME PROCESS. TROUBLESHOOTING WAS PERFORMED .THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7686664 ↗
  • InjuryJul 5, 2018Obstruction of Flow; Obstruction of Flow

    CUSTOMER REPORTED VIA PHONE CALL HOSPITALIZATION AND NO DELIVERY ON THE INSULIN PUMP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 326 MG/DL. CUSTOMER WENT TO THE HOSPITAL ON (B)(6) 2018 AT 11 PM FOR CHEST PAINS NOT DIABETES RELATED. TROUBLESHOOTING FOR NO DELIVERY WAS PERFORMED. CUSTOMER ADVISED THEY CHANGED OUT THEIR INFUSION SET AND RESERVOIR MULTIPLE TIMES HOWEVER THEY CONTINUED TO RECEIVE NO DELIVERY ALARMS. CUSTOMER ADVISED THEY TRIED ALL REMEDIES AND THE ISSUE REMAINED UNRESOLVED. 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: Hyperglycemia

    MAUDE report 7665261 ↗
  • MalfunctionJul 3, 2018Failure to Cycle; Failure to Cycle

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS APPEARED NORMAL. THE POSSIBLE CAUSE OF THE ALARM WAS THAT, DURING SEATING THE FORCE SENSOR WAS NOT DETECT THE RESERVOIR. THE TROUBLESHOOTING WAS PERFORMED FOR PRIME REWIND. 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 7657760 ↗
  • MalfunctionJul 2, 2018Human-Device Interface Problem; Human-Device Interface Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 365 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED INSULIN PUMP DISPLAY RETURNED FOR SEVERAL MOMENTS, BUT THEN WENT BLANK AGAIN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND THE DISPLAY DID NOT RETURN. 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 7657198 ↗
  • InjuryJun 25, 2018Device Displays Incorrect Message

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE RECEIVING A CHANGE SENSOR ALERT. CUSTOMER CHANGED THE SENSOR YESTERDAY AND THE SENSOR IS LESS THAN 20 HOURS OLD. CUSTOMER STATED THAT THEY ALSO RECEIVED A CALIBRATION ERROR AND HAD SENSOR GLUCOSE VS. BLOOD GLUCOSE ISSUES. CUSTOMER'S SENSOR GLUCOSE WAS 80 MG/DL, BUT THEIR BLOOD GLUCOSE WAS 403 MG/DL. CUSTOMER TREATED WITH THE PUMP AND STATED THAT THEY WERE OKAY TO TROUBLESHOOT. CUSTOMER HAD A BAD SENSOR ALERT AFTER A 2ND CONSECUTIVE CALIBRATION ERROR. CUSTOMER WAS ADVISED TO REMOVE AND CHANGE THE SENSOR. CUSTOMER WAS EXPERIENCING INTERMITTENT CALIBRATION ERROR ALERTS AND WAS ADHERING TO PROPER PROTOCOL. CUSTOMER WAS ALSO ADVISED TO CHANGE THE SITE AND RETURN THE SENSOR IN USE. CUSTOMER WAS OFFERED A REPLACEMENT FOR THE SENSOR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 7632966 ↗
  • MalfunctionJun 13, 2018Crack; Material Protrusion/Extrusion

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THERE WAS A CRACK NEAR THE RESERVOIR COMPARTMENT AND STOPS AT THE SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED AND NOTICED THAT THE RESERVOIR WASHER WAS STICKING OUT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7599422 ↗

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

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Sources and updates

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