Paradigm® REAL-Time Revel™ MMT-523RNAS (UDI 00643169476509)Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 00643169476509), received between May 26, 2017 and Jul 9, 2020 — classified as 38 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (23 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 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2020Display 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

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD ESCAPE AND ACT BUTTONS LITTLE HARDER TO PUSH AND SCRATCHES ON SCREEN MADE IT HARDER TO SEE. 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 10249089 ↗
• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING LOW BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL WAS 40MG/DL. TROUBLESHOOTING WAS PERFORMED FOR LOW BLOOD GLUCOSE. CUSTOMER HAD ISSUE WITH SENSOR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Blood Loss; Hypoglycemia

  MAUDE report 9954039 ↗
• MalfunctionMar 12, 2020Premature Discharge of Battery; Obstruction of Flow; Premature Discharge of Battery; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CLEARED BASAL SETTINGS ON ONE OCCASION AND ALSO HAD EXPERIENCED RANDOM NO DELIVERY ALARMS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9822130 ↗
• InjuryMar 6, 2020Adverse 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 OVER 600 MG/DL AT THE TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE OF THE CUSTOMER WAS 95 MG/DL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER REPORTED THAT 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 REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER TREATED WITH MANUAL INJECTION. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9797248 ↗
• InjuryMar 5, 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 PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 600 MG/DL AT THE TIME OF INCIDENT. CUSTOMER HAVING ANOTHER RELEVANT BLOOD GLUCOSE VALUE WAS 95 MG/DL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE. CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER DECLINED THE TROUBLESHOOTING FOR THE INSULIN PUMP. CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. DRIVE SUPPORT CAP APPEARED TO BE NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9796255 ↗
• MalfunctionFeb 24, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM. THE CUSTOMER STATED THEY WERE ABLE TO COMPLETE THE REWIND PROCESS. CUSTOMER REPORTED THE DRIVE SUPPORT CAP APPEARED NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9743845 ↗
• MalfunctionFeb 3, 2020Device Alarm System; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Device Alarm System; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S BUTTONS WERE HARD TO PRESS AND HAD MOTOR ERROR ALARMS TWICE. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD RANDOM NO DELIVERY ALARMS. CUSTOMER DECLINED TO REPORT 24 HOURS TECHNICAL SUPPORT DEPARTMENT. CUSTOMER STATED THAT THE REWOUND WAS LOUDER AND SLOWER. 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 9658456 ↗
• MalfunctionDec 18, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Insufficient Device Problem Information; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Insufficient Device Problem Information; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SCRATCHES ON THE SCREEN THAT AFFECTED THE VISIBILITY, CRACK ON THE RIGHT OF THE SCREEN ABOUT A HALF INCH BIG, INSULIN WAS SQUIRTING DURING PRIMING RATHER THAN A SLOW DRIP, HAD MOTOR ERROR, BUTTON ERROR AND A AND E CODE ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL AS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9488190 ↗
• InjuryDec 10, 2019Obstruction of Flow; No Apparent Adverse Event; Patient Device Interaction Problem; Obstruction of Flow; No Apparent Adverse Event; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH AND LOW BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 465 - 20 MG/DL AND OTHER BLOOD GLUCOSE LEVEL WAS OVER 200 MG/DL. CUSTOMER ALSO REPORTED CHIPPING IN THE RESERVOIR RING WHEN THE CUSTOMER TOOK OUT THE OLD RESERVOIRS, THE PUMP SCREEN WAS BLOTCHY, SQUIRTED INSULIN WHILE PRIMING AND UNEXPLAINED NON DELIVERY ALARMS. CUSTOMER REPORTED THAT THERE WAS PHYSICAL DAMAGE TO THE INSULIN PUMP'S RESERVOIR LIP RING AND THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. 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; Hypoglycemia

  MAUDE report 9443170 ↗
• InjuryDec 2, 2019Adverse 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¿S PERSONAL ASSISTANT REPORTED VIA PHONE CALL THAT CUSTOMER WAS ADMITTED IN THE INTENSIVE CARE UNIT DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 629 MG/DL. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS LOW BACK PAIN. THE CUSTOMER WAS TREATED WITH INSULIN DRIP. CUSTOMER STATED THAT DRIVE SUPPORT CAP APPEARED NORMAL. SELF TEST WAS COMPLETED AND BASED ON CUSTOMER REPORT CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 9399627 ↗
• MalfunctionNov 8, 2019Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERRORS AND BUTTONS WERE HARDER AND TOOK FEW TIMES TO RESPOND. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THERE WAS FRACTURE ON TOP RIGHT SIDE OF INSULIN PUMP, BACK LIGHT WAS MORE DIM AND INSULIN WAS MAKING WEIRD NOISE WHEN REWINDING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9294969 ↗
• MalfunctionNov 6, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  CUSTOMER'S WIFE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PARTIAL DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THEY TRY TO ADJUST SCREEN OF INSULIN PUMP AND FUZZY LINES THAT COME UP INTO AND IT GOES BLANK WHEN CUSTOMER PRESSES ACT ON INSULIN PUMP. CUSTOMER STATED THAT WHEN THEY GOES INTO MENUS THAT THERE WAS LINES AND THEY CANNOT MAKE OUT THE WORDS. CUSTOMER STATED THAT THE INSULIN PUMP WAS NEITHER DROPPED NOR BUMPED. 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 9283290 ↗
• MalfunctionOct 25, 2019Device Difficult to Program or Calibrate; Priming Problem; Device Difficult to Program or Calibrate; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 331 MG/DL. CUSTOMER HAS BEEN EXPERIENCING HIGHS BLOOD GLUCOSE AND NOTICES HIGH AFTER LUNCH. CUSTOMER WAS THIS MORNING ON A FAST AND BLOOD GLUCOSE WAS 268 MG/DL, WHEN SHE WENT TO REWIND THE INSULIN PUMP SHE HAD TO PRESS THE BUTTON 2 TO 3 TIMES TO GET IT TO REWIND. CUSTOMER STATED WHEN SHE WOULD PRESS THE BUTTON IT WENT BACK TO THE HOME SCREEN, IT WENT BACK TO REWIND AND THE ACT BUTTON WAS NOT RESPONDING TO REWIND. CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH BOLUS. CUSTOMER DECLINED TROUBLESHOOTING FOR PRIME ANOMALY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9237109 ↗
• MalfunctionSep 24, 2019Device Difficult to Program or Calibrate; Battery Problem; Adverse Event Without Identified Device or Use Problem; Power Problem; Device Difficult to Program or Calibrate; Battery Problem; Adverse Event Without Identified Device or Use Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL BUTTONS OF THE INSULIN PUMP WERE LESS RESPONSIVE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THEY HAD RECEIVED LOW BATTERY ALERT AFTER A WEEK AND ALSO A FAILED BATTERY TEST ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9108906 ↗
• MalfunctionSep 23, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THERE WAS CRACK ON RESERVOIR LIP RING AND RING FELL OFF. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE RESERVOIR DID LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. 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 9103371 ↗
• MalfunctionSep 19, 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 THERE WERE SCRATCHES ON SCREEN AND IT WAS HARD TO SEAT TIMES. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT BUTTONS OF INSULIN PUMP WAS HARD TO PRESS, MINOR CRACKS AROUND CORNERS OF INSULIN PUMP AND LIGHT WAS DIMMER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9085813 ↗
• MalfunctionSep 19, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED BUTTON ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 268 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THEY WOULD CONTINUE TO USE THE CURRENT INSULIN PUMP AND THEN SWITCH TO THE LOANER INSULIN PUMP IF BUTTON ERRORS CONTINUE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9085313 ↗
• MalfunctionSep 17, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE TOP PART OF THE BATTERY COMPARTMENT INCLUDING THE THREADS BROKEN OFF. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ACCIDENTALLY THREW THE BOX, ENVELOPE AND RETURNED THE LABEL FOR THE INSULIN PUMP. THE CUSTOMER STATED THAT THE RESERVOIR LIP RING WAS DAMAGED BUT THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO THE INSULIN PUMP. 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: Hyperglycemia

  MAUDE report 9080111 ↗
• InjurySep 11, 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 THE CUSTOMER EXPERIENCED HYPOGLYCEMIA. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 40 MG/DL TO 60 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR, UNOMED INF SET.

  Patient problems: Hypoglycemia

  MAUDE report 8988029 ↗
• InjuryAug 14, 2019No Display/Image; Moisture or Humidity Problem; No Apparent Adverse Event; No Display/Image; Moisture or Humidity Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 587 MG/DL AT THE TIME OF THE INCIDENT AND CURRENT BLOOD GLUCOSE LEVEL WAS 139 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS IN DROPPED IN THE POOL AND IT WAS NOT WORKING. CUSTOMER STATED THAT THE SCREEN WAS FOGGED OVER AND COULD NOT BARELY SAW IT. CUSTOMER¿S HIGH BLOOD GLUCOSE WAS TREATED WITH MANUAL INJECTION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8891901 ↗
• MalfunctionAug 12, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP FELL OUT OF HER POCKET AND HIT THE FLOOR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE BOTTOM OF THE INSULIN PUMP WAS PUSHED OUT. 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: Hyperglycemia; Hypoglycemia

  MAUDE report 8882619 ↗
• MalfunctionAug 1, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR COMPARTMENT WAS CRACKED AND CHIPPED BUT RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER WAS ADVICE THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVICE TO DISCONTINUE USE OF THE 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 8849258 ↗
• MalfunctionJul 31, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD DAMAGE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 95 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER STATED THAT THE RESERVOIR COMPARTMENT WAS CRACKED. THE CUSTOMER STATED THAT THE RESERVOIR ABLE TO LOCK IN 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 PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8844446 ↗
• MalfunctionJul 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTON OF INSULIN PUMP WAS STICKING OUT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THE INSULIN PUMP¿S DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE INSULIN PUMP AND WAS ADVISED TO REPLACE THE INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8810624 ↗
• MalfunctionJul 5, 2019Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR AND THE INSULIN PUMP IS NOT WORKING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 275 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DID NOT REPORT AN E70 ALARM. 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 8763053 ↗

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-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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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