Paradigm® REAL-Time Revel™ MMT-523RNAL (UDI 00643169221536)Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 00643169221536), received between Jun 5, 2017 and Jan 14, 2020 — classified as 1 death, 38 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (19 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 103 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2020Computer Software Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Battery Problem; Patient Device Interaction Problem; Computer Software Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Battery Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP SCREEN WERE HARDER TO READ DUE TO SCRATCHES AND SCUFFS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT BATTERY CHANGED FREQUENTLY AND ERROR CODE MESSAGE RECEIVED. CUSTOMER STATED THAT INSULIN PUMP REWIND WAS SLOWER, ACT BUTTON WERE STICKY, LOCKED UP AND UNRESPONSIVE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9586562 ↗
• MalfunctionNov 13, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THEY FILLED THE VILE AND WHEN THEY STARTED TO FILL IT WAS REWINDING. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND WAS ABLE TO COMPLETE REWIND. THE CUSTOMER WAS REFERRED TO THE BACK-UP PLAN AS PER THE HEALTHCARE PROFESSIONAL¿S INSTRUCTIONS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9313879 ↗
• DeathNov 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN AN ACCIDENT. THE CAUSE OF DEATH WAS A BRAIN HEMORRHAGE. THE CALLER DID NOT STATE WHETHER THE CUSTOMER HAD ANY ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. IT IS UNKNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. IT IS UNKNOWN IF THE CUSTOMER WAS USING SENSORS. NO FURTHER INFORMATION WAS PROVIDED. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Death

  MAUDE report 9276407 ↗
• MalfunctionSep 16, 2019Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Device Difficult to Program or Calibrate; Visual Prompts will not Clear

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED BUTTON ERROR ALERT AND FROZEN DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE WAS 138 MG/DL. THE CUSTOMER STATED THAT THE THEY OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME DID NOT ADVANCED. CUSTOMER STATED THAT ALARM DID NOT RECUR. 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 9069155 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WAS IN EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF OVER 500 MG/DL AND COMA DUE TO CAR ACCIDENT ON (B)(6) 2019. CUSTOMER STATED THAT THEY HAD NO ISSUE WITH INSULIN PUMP AND HAD ISSUE DUE TO USER ERROR. CUSTOMER WAS TREATED WITH MANUAL INJECTION AND INSULIN DRIP. DRIVE SUPPORT CAP WAS NORMAL AND CUSTOMER WAS USING INSULIN PUMP WITHIN 48 HOURS OF EVENT. BASED ON CUSTOMER REPORT CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Blood Loss; Coma; Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 9068776 ↗
• MalfunctionSep 12, 2019Moisture or Humidity Problem; Moisture or Humidity Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT HE WAS AT THE POOL WITH THE INSULIN PUMP AND IT WAS EXPOSED TO MOISTURE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER WAS ADVISED THAT IT WAS NOT SAFE TO USE INSULIN PUMP. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND RECOMMENDED CUSTOMER REFER TO BACK UP PLAN PER HEALTHCARE PROFESSIONAL'S INSTRUCTIONS. CUSTOMER DID NOT HAD BACK UP PLAN AVAILABLE. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9002725 ↗
• MalfunctionSep 11, 2019Premature Discharge of Battery; Premature Discharge of Battery

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED UNEXPECTED RESTART ALARM WAS REOCCURRED AFTER INSERTING A NEW BATTERY. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8987492 ↗
• MalfunctionAug 12, 2019Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS WERE UNRESPONSIVE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD UNEXPECTED NO DELIVERY ALARM. CUSTOMER DECLINED TROUBLE SHOOT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8882801 ↗
• InjuryJul 31, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2019, WITH BLOOD GLUCOSE OF 400 MG/DL. THE CUSTOMER WAS TREATED WITH INTRAVENOUS DRIP. CUSTOMER DECLINED FOR TROUBLE SHOOT FOR THE PAST HIGH BLOOD GLUCOSE EVENT. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND THE DRIVE SUPPORT CAP WAS FLUSHED. 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 NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; No Consequences Or Impact To Patient

  MAUDE report 8844488 ↗
• MalfunctionJul 10, 2019Battery Problem; Power Problem; Patient Device Interaction Problem; Priming Problem; Battery Problem; Power Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP'S GEAR WAS MUCH SLOWER WHEN PRIMING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD DIMINISHED BATTERY LIFE EVEN THOUGH FRESH NEW TEMP BATTERIES, FAILED BATTERY TEST EVEN AFTER NEW BATTERY CHANGE AND CHUNK OUT OF BATTERY AREA TOP PART. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8774804 ↗
• MalfunctionJul 5, 2019Mechanical Problem; Moisture or Humidity Problem; Mechanical Problem; Moisture or Humidity Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE AND MOTOR ERROR ALARM DETECTED. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS OVER 478 MG/DL AT TIME OF INCIDENT AND OTHER BLOOD GLUCOSE WAS 176 MG/DL. CUSTOMER TREATED WITH INSULIN PUMP. TROUBLESHOOTING WAS DECLINED FOR HIGH BLOOD GLUCOSE LEVEL. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8763134 ↗
• InjuryJul 3, 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 400 MG/DL AT THE TIME OF INCIDENT. CUSTOMER TREATED WITH INSULIN PUMP AND MANUAL INJECTION. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER REPORT CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER STATES THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER PERFORMED THE SELF-TEST AND ABLE TO PASSED THE TEST. CUSTOMER DECLINED TO CHECK FOR THE PRESENCE OF LEAKS OR AIR BUBBLES IN THE TUBING OR RESERVOIR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 8756829 ↗
• MalfunctionJun 24, 2019No Display/Image; Patient Device Interaction Problem; Priming Problem; No Display/Image; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS UNRESPONSIVE TO NEW BATTERY. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE INSULIN PUMP DURING REWIND OR PRIME HAD A GRINDING NOISE AND WAS LOUDER, PLASTIC ON RESERVOIR CAP WAS BREAKING AND CRACKS AROUND RESERVOIR COMPARTMENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8729843 ↗
• MalfunctionMay 8, 2019Premature Discharge of Battery; Unexpected Shutdown; Premature Discharge of Battery; Unexpected Shutdown

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD EXTERNAL RAM CRC ERROR AND UNEXPECTED RESTART ALERT. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND WAS ABLE TO REWIND THE INSULIN PUMP. CUSTOMER PERFORMED TROUBLESHOOTING AND RECEIVED ANOTHER UNEXPECTED RESTART ALERT AFTER BATTERY CHANGE. CUSTOMER ALSO STATED THAT THE THEY HAD CHANGED BATTERY SEVERAL TIMES AND IT HAPPENED EVERY TIME SO THEY DID NOT HAVE DO IT AGAIN AND INSULIN PUMP ALARMED UNEXPECTED RESTART ALERT. CUSTOMER ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN DUE TO EXTERNAL RAM CRC ERROR. THE INSULIN PUMP WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8590140 ↗
• MalfunctionApr 18, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS OF INSULIN PUMP WERE UNRESPONSIVE. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATES THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8526929 ↗
• MalfunctionApr 18, 2019Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS HAVING UNRESPONSIVE BUTTONS DECLINED 24 HOUR AND DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER REPORTS THREADING WHERE RESERVOIR GOES IN WAS CRACKED OFF AND THERE WAS DIMMED BACK LIGHT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8526852 ↗
• MalfunctionApr 8, 2019Obstruction of Flow; Patient Device Interaction Problem; Priming Problem; Obstruction of Flow; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATES THERE WAS ALSO A CRACK ON THE SIDE OF THE DISPLAY WINDOW. CUSTOMER STATES THAT THE MDT TAB IS MISSING FROM THE PUMP. CUSTOMER ALSO STATES THAT RESERVOIR FITS AND LOCKS INTO PLACE WHEN INSERTED INTO INSULIN PUMP LOOSENED AND CUSTOMER STATES THAT INSULIN PUMP WAS NOT BUMPED OR DROPPED. 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 8490410 ↗
• MalfunctionMar 28, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER'S REPORTED VIA PHONE CALL THAT TOP OF THE RESERVOIR COMPARTMENT WAS CHIPPING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK IN 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. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8458767 ↗
• MalfunctionMar 27, 2019Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED UNEXPECTED RESTART ALARMED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 117 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND WAS UNABLE TO COMPLETE REWIND. CUSTOMER ALSO STATED THAT THE RECEIVING ANOTHER UNEXPECTED RESTART ALARMED AFTER A BATTERY CHANGE. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8456712 ↗
• MalfunctionMar 22, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DAMAGED. CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THE RESERVOIR AND BATTERY COMPARTMENT WAS BROKEN. RESERVOIR WAS ABLE TO LOCK IN 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 DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8442711 ↗
• MalfunctionMar 16, 2019Patient 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 UNKNOWN AT THE TIME OF THE INCIDENT. RESERVOIR COMPARTMENT DAMAGE. THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO PUMP. 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: No Consequences Or Impact To Patient

  MAUDE report 8427034 ↗
• InjuryMar 14, 2019Mechanical Problem; Detachment of Device or Device Component; Patient Device Interaction Problem; Mechanical Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  CUSTOMER CALLED AND REPORTED THAT THEY GOT HOSPITALIZED DUE TO LOW BLOOD GLUCOSE AND ATRIAL FIBRILLATION ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 65 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 168 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER WAS GIVEN FOOD, GLUCOSE TABLETS, AND INTRAVENOUS GLUCOSE TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER STATED THE PUMP DRIVE SUPPORT CAP WAS FLUSH AND HAD A CRACK. TROUBLESHOOTING WAS NOT COMPLETED. THE CUSTOMER RECEIVED A MOTOR ERROR WHEN CHANGING THE PUMP BATTERY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8419268 ↗
• MalfunctionMar 8, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER STATE THAT THEY WERE UNABLE TO CLEAR THE ALARM AND UNABLE TO REWIND THE INSULIN PUMP. CUSTOMER REPORTS THEY ARE UNABLE TO DESCRIBE THE POSSIBLE DAMAGE TO THE DRIVE SUPPORT CAP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8402717 ↗
• MalfunctionMar 7, 2019Power Problem; Patient Device Interaction Problem; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD TO TILT AT THE TIME TO VIEW THE SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THEY HAD TO TURN ON THE BACK LIGHT TO VIEW SCREEN AS FORMATION ON SCREEN BECOMES DISTURBED AT TIMES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8398775 ↗
• MalfunctionMar 6, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR DURING REWIND. THE 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 8393767 ↗

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-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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-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-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-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