MiniMed® 530G MMT-551NAB (UDI 00643169736016)Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00643169736016), received between Aug 30, 2017 and Jul 29, 2020 — classified as 33 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (7 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2020Device Alarm System; Device Difficult to Program or Calibrate; Battery Problem; Device Alarm System; Device Difficult to Program or Calibrate; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE STICKING. CUSTOMER STATED INSULIN PUMP HAD CHANGING BATTERY MORE FREQUENTLY, DIMINISHED BATTERY LIFE, DID NOT HEAR ALARMS. 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 10337009 ↗
• MalfunctionDec 10, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTON DOES NOT WORK. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE UP BUTTON WAS HARD TO PRESS. CUSTOMER OBSERVE TIME CLOCK FOR ONE MINUTE AND TIME ADVANCES. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE 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 9444212 ↗
• InjurySep 25, 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 EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9114648 ↗
• InjuryAug 6, 2019No Display/Image; No Apparent Adverse Event; No Display/Image; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED THE HYPERGLYCEMIA. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 312 MG/DL. THE CUSTOMER¿S OTHER BLOOD GLUCOSE WAS 450 MG/DL. THE CUSTOMER STATED THAT INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER STATES THE CONTACTS ON THE BATTERY CAP WAS NOT MISSING OR DAMAGED. CUSTOMER STATES BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATES THE SPRING WAS NEITHER DAMAGED NOR CORRODED. THE CUSTOMER ADVICE TO INSERT THE NEW BATTERY. CUSTOMER STATES THE DISPLAY DID NOT RETURN. CUSTOMER ADVISED TO REMOVE BATTERY FOR 10 MINUTES. ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8863032 ↗
• InjuryAug 2, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 418 MG/DL. CUSTOMER STATED THAT SHE WAS ABOUT TO EAT HER LUNCH BUT THEN NOTICED A MESSAGE IN THE INSULIN PUMP THAT SAYS NO DELIVERY. CUSTOMER WAS ADVISED THAT THE POSITION OF MOTOR MAY HAVE SHIFTED. CUSTOMER WAS ADVISED TO DISCONNECT AT THE QUICK RELEASE. CUSTOMER WAS ASSISTED IN PERFORMING A 5.0 UNIT FIXED PRIME. CUSTOMER STATED THE INSULIN EXITED. CUSTOMER WAS ABLE TO REMOVE SET AT THIS TIME TO TEST SITE PORTION OF INFUSION SET. CUSTOMER WAS ADVISED TO REMOVE THE SET AND EXAMINE THE CANNULA. CUSTOMER STATED THE CANNULA WAS BENT. CUSTOMER REPORTED THAT THEY ALREADY HAD HER MANUAL INJECTIONS AND THEY JUST BOLUS WHILE THEY HAD SUCCESSFULLY CLEARED THE ALARM. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8853754 ↗
• InjuryJul 23, 2019Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH INSULIN PUMP FOR HIGH BLOOD GLUCOSE LEVEL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8814650 ↗
• MalfunctionJul 11, 2019Premature Discharge of Battery; Power Problem; Premature Discharge of Battery; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO THE REPLACE BATTERY ALERT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 349 MG/DL. THE CUSTOMER STATES THE BATTERY WAS NOT PREVIOUSLY USED. CUSTOMER STATED THAT UNEXPECTED ERROR ALARM REOCCURRED AFTER THE NEW BATTERY CHANGE. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER ABLE TO COMPLETE REWIND. CUSTOMER ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8779924 ↗
• MalfunctionJul 2, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER'S FAMILY REPORTED VIA PHONE CALL THAT THE BUTTONS ARE HARD TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DISPLAY DID NOT RETURNED BACK. THE CUSTOMER WAS ALSO REPORTED THAT BUTTONS WERE WORN DOWN AND CANNOT SEE THE UP OR DOWN ARROW. THE CUSTOMER WAS ADVISED TO REPLACE AND 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 8752240 ↗
• MalfunctionJun 19, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMERS PARENT REPORTED VIA PHONE CALL THAT THEIR SON INSULIN PUMP HAD KEYPAD ANOMALY THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 6.3 MMOL/L. THE CUSTOMER REPORTED THAT THE BUTTONS WERE HARD TO PUSH AND KEYS ON PUMP ARE VERY HARD TO PRESS AND SHE NEEDS TO PRESS THEM SEVERAL TIMES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8711179 ↗
• MalfunctionMay 10, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD LINE ON THE SCREEN AND OCCASIONALLY IT GIVE BACK LIGHT SOMETIMES NOT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 75 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8598757 ↗
• InjuryApr 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND LOOSE DRIVE SUPPORT CAP. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 600 MG/DL AT THE TIME OF THE INCIDENT AND CURRENT BLOOD GLUCOSE WAS 444 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH INSULIN PUMP AND PEN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8526145 ↗
• MalfunctionApr 18, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP MOTOR POSITION ENCODER ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 85 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO REPLACE AND 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 8525885 ↗
• MalfunctionApr 15, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED NO DELIVERY ALARMS, SLOWER REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8513574 ↗
• MalfunctionFeb 7, 2019No Display/Image; Power Problem; No Display/Image; Power Problem

  THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD BATTERY LIFE DIMINISHED AND INSULIN PUMP WILL TURN OFF. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE NEW BATTERY DIMINISHED IN ONE DAY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8319086 ↗
• InjuryJan 8, 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 LEGAL REPRESENTATIVE REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8230033 ↗
• MalfunctionJan 4, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COSMETIC DAMAGE AND RIM OF THE RESERVOIR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 117 MG/DL. CUSTOMER WAS ADVISED TO REVERT TO BACKUP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8216433 ↗
• InjuryNov 6, 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 THE HYPERGLYCEMIA CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE CUSTOMER¿S OTHER BLOOD GLUCOSE LEVEL WAS 200,180,381 MG/DL. THE CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. THE CUSTOMER DECLINED THE TROUBLESHOOT FOR THE HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8041504 ↗
• MalfunctionNov 5, 2018Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP SCREEN WAS FADE OUT. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER ALSO STATES REWIND ANOMALY. DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8040041 ↗
• InjuryOct 4, 2018No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER¿S REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 470 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. THE CUSTOMER STATED THAT THEY TOOK CAT'S INSULIN BY ACCIDENT, THE CAT'S INSULIN WAS 40U AND THE CUSTOMER NORMALLY TAKES 100U. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7934660 ↗
• InjurySep 26, 2018Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE CONTACTED HEALTHCARE PROFESSIONAL DUE TO HIGH BLOOD GLUCOSE LEVEL OF 512 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT ABLE TO REWIND. DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATE THAT THE INSULIN PUMP WAS EXPOSED TO X-RAY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7908996 ↗
• InjurySep 25, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE VALUE. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 512 MG/DL. THE CUSTOMER'S CURRENT BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE VALUE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7905368 ↗
• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED NO DELIVERY ALARM AFTER CHANGING SET AND RESERVOIR BLOOD GLUCOSE WAS 476 MG/DL E OF INCIDENT. THE CUSTOMER TROUBLESHOOTED AND WAS ADVISED TO SET CHANGE AND RESERVOIR CHANGE. THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO REVERT TO BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7831946 ↗
• MalfunctionAug 10, 2018Priming Problem; Priming Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SEVERAL ISSUES. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THE INSULIN PUMP BUTTONS WERE HARD TO PRESS, BATTERY LIFE DOES NOT LAST LONG, INSULIN SQUIRTS OUT DURING PRIME PROCESS, AND HAD NO DELIVERY ALARMS. CUSTOMER DECLINED TROUBLESHOOTING. INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7773226 ↗
• InjuryJun 14, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 4 TO 600 MG/DL. CUSTOMER ALSO HAD BLOOD GLUCOSE LEVEL OF 411 MG/DL AND 240 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7601586 ↗
• InjuryJun 13, 2018Insufficient Flow or Under Infusion

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 574MG/DL. THE CUSTOMER HAD SYMPTOMS LIKE THIRSTY, STOMACH PAINS, AND URINATING A LOT AND TREATED WITH MANUAL INJECTION. CUSTOMER¿S CURRENT BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER ALLEGES PUMP WAS UNDER DELIVERY .TROUBLESHOOTING WAS PERFORMED FOR HIGH READINGS. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7598653 ↗

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