MiniMed® 530G MMT-551LNAB (UDI 00643169932999)Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00643169932999), received between Dec 27, 2017 and Oct 12, 2020 — classified as 16 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Power Problem” (11 reports).

2 other recalls cover devices cleared under the same FDA submission (P120010); 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2020Communication or Transmission Problem; Communication or Transmission Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SENSOR GOT LOST SENSOR ALARM AND LOSS OF COMMUNICATION. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10668232 ↗
• MalfunctionJun 23, 2020Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BUTTONS TO PRESS MULTIPLE TIMES TO GET RESPONSE, UP AND DOWN ARROW BUTTON. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER STATED THAT INSULIN PUMP REJECTED NEW BATTERIES BUT NOT SURE IF IT WAS THE PUMP OR BAD BATTERY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10183172 ↗
• MalfunctionNov 16, 2019Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER WERE ABLE TO CLEAR THE ALARM AND ABLE TO COMPLETE REWIND. AFTER TROUBLESHOOTING ALARM WAS OCCURRED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9333101 ↗
• MalfunctionOct 31, 2019Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT THE SENSOR HAD CALIBRATION ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 390 MG/DL, AND OTHER RELEVANT BLOOD GLUCOSE LEVEL WAS 193 MG/DL. THE CUSTOMER ALSO STATED THAT THEY PUT NEW SENSOR AND THEY GOT CONTINUOUS SENSOR ERROR. THE CUSTOMER PASSED THE TEST PLUG PROCEDURE. CUSTOMER WAS USING BLUE TEST PLUG. CUSTOMER STATED THAT THE LED BLINKED ON AND OFF WHEN CONNECTED TO THE TEST PLUG. CUSTOMER STATED THAT THERE WAS NO DAMAGE TO THE CONNECTION BRIDGE OR PINS AND SENSOR FEATURE WAS ON. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR SENSOR ERROR. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9264832 ↗
• MalfunctionOct 6, 2019Obstruction of Flow; Battery Problem; Power Problem; Insufficient Device Problem Information; Obstruction of Flow; Battery Problem; Power Problem; Insufficient Device Problem Information

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PUMP ERROR ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT INSULIN PUMP WAS REJECTED NEW BATTERIES AND RECEIVED NO DELIVERY ALARMS DURING PRIMING PROCESS ALSO RAINBOW EFFECTS ON SCREEN OF INSULIN PUMP. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9160398 ↗
• MalfunctionAug 27, 2019Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS UNABLE TO REWIND. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED BATTERY OUT LIMIT AND WAS ABLE TO CLEAR THE ALARM. 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 NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934877 ↗
• MalfunctionAug 7, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP KEYPAD WAS UNRESPONSIVE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS NOT ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE UP AND DOWN BUTTON WAS NOT WORKING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8872500 ↗
• InjuryAug 1, 2019Device Alarm System; No Display/Image; Power Problem; Device Alarm System; No Display/Image; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 500 MG/DL AND 195 MG/DL. THE CUSTOMER REPORTED THAT THEY TREATED HIGH BLOOD GLUCOSE LEVEL WITH THE MANUAL INJECTIONS. THE CUSTOMER DID NOT MENTION ANY SYMPTOM RELATED TO HIGH BLOOD GLUCOSE LEVEL. CUSTOMER STATED THAT SHE CHANGED THE BATTERY PRIOR TO HER HAVING THE HIGH BLOOD GLUCOSE LEVELS, CUSTOMER STATED SHE DID NOT GET ANY ALARMS EITHER. CUSTOMER CHECKED THE ALARM HISTORY AND FOUND LOW BATTERY ONLY. CUSTOMER STATED SHE HAD TO MESS WITH IT FOR LIKE AN HOUR BEFORE SHE COULD GET THE INSULIN PUMP TO RESPOND. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE EVENT AND BLANK DISPLAY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8849531 ↗
• MalfunctionJul 17, 2019Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER'S FAMILY REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. A COLD RESET WAS PERFORMED ALARM RECURRING DURING NORMAL INSULIN PUMP USE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 65 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ADVICE 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 8796968 ↗
• MalfunctionMay 29, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER¿S MOTHER WAS REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DAMAGED AT THE KEYPAD. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 73 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONTINUED 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 8649358 ↗
• MalfunctionMay 29, 2019Circuit Failure; Intermittent Communication Failure; Circuit Failure; Intermittent Communication Failure

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A WATCHDOG TIME ERROR AND IOP TEST FAILURE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM AND REWIND THE INSULIN PUMP. THE CUSTOMER REPORTED THAT THE INSULIN PUMP PASSED THE SELF TEST. 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 8648534 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 22 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS GIVEN INTRAVENOUS FLUIDS TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS A DIABETIC COMA. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS COMPLETED AND NO ISSUES WERE FOUND. THE CUSTOMER HAD DONE DIALYSIS EARLIER THAT MORNING AND WAS GOING TO GET SOMETHING TO EAT. THE CUSTOMER ALSO REPORTED SENSOR GLUCOSE VERSUS BLOOD GLUCOSE DIFFERENCES. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Coma; Hypoglycemia

  MAUDE report 8618812 ↗
• MalfunctionMay 17, 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 REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA ON (B)(6) 2019 WITH BLOOD GLUCOSE LEVEL WAS 485 MG/DL AT TIME OF INCIDENT. CUSTOMER STATES THAT THEY HAD HARD TIME TO BREATHING AND THEY ALSO HOSPITALIZE DUE PNEUMONIA. THE CUSTOMER WAS TREATED WITH INJECTIONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8618646 ↗
• MalfunctionMay 7, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP'S SCREEN HAD RAINBOW EFFECT AND THE DARK SPOT ON SCREEN. 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 8585386 ↗
• MalfunctionApr 27, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. INSULIN PUMP HAD NO DELIVERY ALARM. CUSTOMER STATED THAT THE BUTTONS OF THE PREVIOUS DEVICE WAS LOCKED UP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8559418 ↗
• MalfunctionApr 18, 2019Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR BUTTONS WERE HARDER TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE ACT BUTTON NOT RESPONSIVE AND SOMETIMES HAS TO PRESS BUTTONS MORE THAN ONCE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8526611 ↗
• MalfunctionApr 9, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A MOTOR ERROR AND ALSO HAD MOTOR POSITION ENCODER ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 328 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED DRIVE SUPPORT CAP WAS APPEARS NORMAL. TROUBLESHOOTING WAS PERFORMED. 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 INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8494850 ↗
• MalfunctionApr 8, 2019Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem

  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 ACT BUTTON WAS HARDER TO PRESS AND REJECTED NEW BATTERY ONCE OR TWICE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8490108 ↗
• MalfunctionMar 29, 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 THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE ACT BUTTON OF THE INSULIN PUMP ARE HARDER TO PRESS. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD RAINBOW EFFECT AND BURN MARK ON THE SCREEN. ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED AND TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8463881 ↗
• MalfunctionMar 27, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD ACT BUTTON HARDER TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8455937 ↗
• InjuryMar 27, 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 REPORTED VIA PHONE CALL THAT THEY HAD A HIGH BLOOD GLUCOSE VALUE OF 400 MG/DL. CUSTOMER'S OTHER BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING SYMPTOMS OF HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. THE DEVICE WAS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8455295 ↗
• MalfunctionFeb 19, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE ACT BUTTON ON THE INSULIN PUMP WAS DIFFICULT TO PRESS. 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 8349204 ↗
• MalfunctionFeb 19, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. 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

  MAUDE report 8349011 ↗
• MalfunctionFeb 14, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS WERE NOT RESPONDING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 145 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND THEY STATED THAT THE TIME WAS ADVANCES. 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 8341578 ↗
• MalfunctionJan 11, 2019No Display/Image; Power Problem; No Display/Image; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BLANK DISPLAY. THE BLOOD GLUCOSE LEVEL WAS AT 264 MG/DL THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO MOISTURE. CUSTOMER STATES THE CONTACTS ON THE BATTERY CAP ARE NEITHER MISSING NOR DAMAGED. DISPLAY DID NOT RETURN AFTER PUMP RESTART. CUSTOMER STATES THAT INSULIN PUMP HAD FAILED BATTERY TEST. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8239205 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P120010. One submission often covers many models, so check the product and lot details in each record.

• Z-1751-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 530G Insulin Pump (MMT-551, MMT-751)
• 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