Paradigm® REAL-Time Revel™ MMT-723RNAL (UDI 00643169221482)Recalls & reported problems

Summary

The FDA's MAUDE database contains 208 adverse event reports that list this exact device (DI 00643169221482), received between Jun 1, 2017 and Mar 27, 2020 — classified as 2 deaths, 81 injuries, 125 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (40 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 208 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2020Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART AND A COLD RESET WAS PERFORMED AND BUTTON ERROR. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM AND ALSO WAS ABLE TO REWIND THE PUMP. CUSTOMER ALSO REPORTED THAT ALARMED DID NOT RECURRED AFTER INSERTING A NEW BATTERY BUT IT RECURRED DURING NORMAL USE. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9887467 ↗
• MalfunctionMar 12, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP ACT BUTTON STUCK AND REWIND HAD TO BE RESTARTED AT TIMES IN ORDER TO COMPLETE. 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 9822784 ↗
• MalfunctionFeb 28, 2020Application Program Version or Upgrade Problem; Loss of Data; Application Program Version or Upgrade Problem; Loss of Data

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MULTIPLE INSULIN PUMP ERRORS. THE CUSTOMER REPORTED THAT AFTER CLEARING ONE ALARM THEY RECEIVED ANOTHER ALARM AND THEN SHOWS A COUNTDOWN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9768577 ↗
• MalfunctionFeb 26, 2020Mechanical Problem; Battery Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Battery Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NON RESPONSIVE AFTER INSERTING THE NEW BATTERY. CUSTOMER ALSO STATED THAT PUMP HAD CRACKED AT THE BOTTOM AN LEFT CORNER OF THE SCREEN. 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 9754081 ↗
• MalfunctionNov 5, 2019Mechanical Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THERE WAS A SCRATCHES ON SCREEN AND SOMETIMES IT IMPAIR VISIBILITY OF DATA. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THEY CHANGED BATTERY ONCE A WEEK. CUSTOMER REPORTED THAT THE INSULIN PUMP SLOWER AND LOUDER DURING REWOUND AND THEY RECEIVED RANDOM NO DELIVERY ALERTS THAT CAUSE PATIENT TO HAVE LOW BLOOD GLUCOSE. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9280185 ↗
• MalfunctionOct 29, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD REWIND ANOMALY. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THEY HAD TO REWIND MULTIPLE TIMES TO FINISH THE PROCESS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9248562 ↗
• InjuryOct 24, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE WAS 429 MG/DL AT THE TIME OF INCIDENT. OTHER BLOOD GLUCOSE VALUE MENTIONED WAS 387 MG/DL. CUSTOMER WAS NOT USING THE INSULIN PUMP WITHIN 48 HOURS OF HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS ASSISTED WITH CHANGING FOR THE INFUSION SET. INSULIN PUMP WAS DAMAGED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9231185 ↗
• InjuryOct 23, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPOGLYCEMIA AND INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 43 MG/DL AT THE TIME OF INCIDENT. CUSTOMER WAS TREATED WITH GLUCOSE TABLETS. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER REPORTED THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER WAS IN EMERGENCY ROOM AS A RESULT OF LOW BLOOD GLUCOSE. CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS OVER DELIVERING. IT WAS REPORTED THAT DURING THE LAST SET CHANGE CUSTOMER RECALLS INSULIN DRIPPING OR SQUIRTING FROM END OF SET BEFORE CONNECTING AT THEIR SITE. CUSTOMER REPORTED THEY HAVE UNDERGONE 2 SURGERIES IN THE LAST MONTH. CUSTOMER REPORTS DEVICE WAS NOT WORN DURING A MEDICAL PROCEDURE OR TESTS AROUND AN MRI. CUSTOMER¿S BLOOD GLUCOSE AS OF NOW WAS 66 MG/DL. CUSTOMER REPORTED THAT SHE WAS RECEIVING A COMPROMISED FORCE SENSOR SYSTEM ERROR ON HER MOM'S PUMP BUT SHE WAS USING IT AND HER MOM GAVE IT TO HER. CUSTOMER TRIED TO CHANGE SET BUT GOT ERROR. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER WAS NOT ABLE TO COMPLETE REWIND. THE DEVICES WILL NOT BE R

  Patient problems: Hypoglycemia

  MAUDE report 9229658 ↗
• MalfunctionOct 23, 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 HAD COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED AND INSULIN PUMP SQUIRTED OUT INSULIN DURING THE MANUAL PRIME PROCESS. CUSTOMER STATED THAT THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP AND THE REWIND MESSAGE OCCURRED AFTER AN ALARM OR ALERT. CUSTOMER STATED THAT THEY WERE STUCK IN REWIND COMPLETE OR BOLUS DELIVERY LOOP. THE CUSTOMER WAS ALSO 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 9222957 ↗
• MalfunctionOct 3, 2019Premature Discharge of Battery; Premature Discharge of Battery

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART, A COLD RESET WAS PERFORMED ALARM HAPPENED AFTER EACH BATTERY REPLACEMENT. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM, ABLE TO COMPLETE 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 PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9149581 ↗
• MalfunctionSep 20, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BUTTON ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT HE WAS UNABLE TO REPLACE THE BATTERY RIGHT AWAY AND WHEN HE REPLACED IT HE STARTED GETTING THE ALARM ON HIS INSULIN PUMP. CUSTOMER STATED HE WAS UNABLE TO CLEAR THE ALARM. THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO SEE THE TIME AS THERE WAS A BLACK CIRCLE ON THE SCREEN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9097243 ↗
• MalfunctionSep 20, 2019Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Patient Device Interaction Problem

  CUSTOMER¿S FAMILY REPORTED VIA PHONE CALL THAT THE KEYS ARE STICKING AND RUNNING UP NUMBERS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE AS THE BOTTLE FELL ON THE INSULIN PUMP. CUSTOMER REPORTED FLUID IN THE RESERVOIR COMPARTMENT. CUSTOMER REPORTED O-RING INSIDE LIP OF RESERVOIR COMPARTMENT WAS NOT MISSING. 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 9096488 ↗
• MalfunctionSep 19, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER'S WIFE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 127 MG/DL. CUSTOMER STATED THAT INSULIN PUMP WAS NOT WORKING AND WHEN THEY GET TO THE FILL TUBING THE ACT KEY WONT WORK BUT THEN IT DID WORK BUT IT WILL ALARM PUMP ERROR. 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 WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9085871 ↗
• MalfunctionSep 16, 2019Mechanical Problem; Mechanical Problem

  CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MOTOR ERROR WHILE REWINDING. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP WAS UNABLE TO REWIND AND DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF INSULIN PUMP AND REVERT TO BACK UP PLAN. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9069555 ↗
• MalfunctionSep 12, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE TIME WAS NOT ADVANCING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9007595 ↗
• InjurySep 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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. CUSTOMER REPORT THEY DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICE DISPATCHED AS A RESULT OF HIGH BLOOD GLUCOSE. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED WITH INSULIN PUMP AND MANUAL INJECTION. CUSTOMER REPORTED THAT THEY FEEL OKAY TO TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8954157 ↗
• MalfunctionAug 29, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP UP ARROW WILL NOT WORK. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THEY REPORTED THAT THE TIME ON THE INSULIN PUMP ADVANCED. 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 8943913 ↗
• MalfunctionAug 22, 2019Premature Discharge of Battery; Unexpected Shutdown; Premature Discharge of Battery; Unexpected Shutdown

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AN UNEXPECTED RESTART ALARM AND EXTERNAL RAM CRC ERROR. THE BLOOD GLUCOSE LEVEL WAS 167 MG/DL. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER ABLE TO COMPLETE REWIND. CUSTOMER HAS EXPERIENCED MULTIPLE UNEXPECTED RESTART ALARMS AFTER BATTERY CHANGE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP, REVERT TO A BACK UP PLAN AND THE INSULIN PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8921057 ↗
• MalfunctionAug 21, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD STUCK BUTTON ALERT AND BUTTON NOT RESPONDING. THE CUSTOMER¿S BLOOD GLUCOSE WAS 136 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ADVICE THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVICE TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO 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 8914645 ↗
• MalfunctionAug 19, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 174 MG/DL. CUSTOMER STATED THAT TIME WAS MOVING FORWARD. 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 8905457 ↗
• InjuryAug 9, 2019Device Alarm System; Display or Visual Feedback Problem; Excess Flow or Over-Infusion; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Device Alarm System; Display or Visual Feedback Problem; Excess Flow or Over-Infusion; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem

  CUSTOMER CALLED AND REPORTED THAT THEY EXPERIENCED LOW BLOOD GLUCOSE WITH BLOOD GLUCOSE OF 39 TO 65 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER DID NOT MENTION HOW THEY TREATED. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER REPORTED A STRIPPED BATTERY CAP, A DIM BACKLIGHT, AND THAT EVERY TIME THEY CHANGED A BATTERY THEY WOULD LOSE THEIR SETTINGS. THE CUSTOMER MENTIONED NOT RECEIVING LOW BATTERY ALARMS, THAT THEY CANNOT HEAR ALARMS, AND RANDOM NO DELIVERY ALARMS. THE CUSTOMER ALSO REPORTED STICKING OR HARD TO PRESS BUTTONS, AND GRINDING SOUNDS DURING PUMP REWIND. THE CUSTOMER BELIEVES THE PUMP IS NOT GIVING THEM CORRECT AMOUNTS OF INSULIN. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE CUSTOMER IS LEGALLY BLIND AND MENTIONED A LOW EVENT CAUSED BY OVER DELIVERY. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8877516 ↗
• MalfunctionAug 6, 2019Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT BUTTONS OF INSULIN PUMP BUTTONS WERE STICKY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO REPORTED THAT BACK LIGHT WAS DIMMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8863400 ↗
• MalfunctionAug 2, 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

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP¿S KEYPAD WAS STICKY AND UNRESPONSIVE. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP REJECTED NEW BATTERY, CUSTOMER NOTICED SCRATCHES AND RAINBOW ON SCREEN. CUSTOMER MENTIONED THAT THEY HEARD UNUSUAL GRINDING NOISES AND HAD ERROR MESSAGES. CUSTOMER HAVE LOST INSULIN PUMP SETTINGS OR INSULIN PUMP LOCKED UP AND BECOME UNRESPONSIVE. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8854427 ↗
• MalfunctionJul 30, 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 ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY WERE AT THE POOL AND GETTING READY TO LEAVE WHEN THE INSULIN PUMP STARTED ALARMING. THE CUSTOMER REPORTED THAT THEY CANNOT DO ANYTHING WITH THE PUMP EVEN IF THEY HAD REPLACED THE BATTERY IT STILL SHOWED BUTTON ERROR. THE CUSTOMER STATED THAT THE TIME ON THE INSULIN PUMP DID NOT ADVANCE. 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 8842419 ↗
• MalfunctionJul 26, 2019Device Difficult to Program or Calibrate; Material Integrity Problem; Power Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTON LESS RESPONSIVE, WERE HARDER TO PRESS, SOMETIMES HAD TO PRESS BUTTONS TWICE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED INSULIN PUMP HAD REJECTED NEW BATTERIES, BATTERY CAP WAS STRIPED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8831738 ↗

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-1749-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
• Z-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• 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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• 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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• 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