MiniMed® 530G MMT-551RNASRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169507951), received between Jun 28, 2017 and Mar 6, 2020 — classified as 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2020No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT RESPONDING. CUSTOMER STATED THAT THE BATTERY COMPARTMENT WAS CRACKED. 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 9796486 ↗
• InjuryFeb 27, 2020Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 448 MG/DL. THE CUSTOMER REPORTED THAT INSULIN PUMP HAD MOTOR ERROR. IT WAS REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9761924 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCING HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL WAS 448 MG/DL,374 MG/DL AT TIME OF INCIDENT. CUSTOMER HAD SYMPTOMS SUCH AS ABDOMINAL PAIN, DIFFICULTY IN BREATHING AND DIARRHEA. CUSTOMER DECLINED TROUBLESHOOTING FOR BLOOD GLUCOSE. CUSTOMER ALSO REPORTED THAT INSULIN PUMP HAD MOTOR ERROR ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Abdominal Pain; Diarrhea; Dyspnea; Hyperglycemia

  MAUDE report 9754079 ↗
• MalfunctionFeb 20, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND MOTOR POSITION ENCODER ERROR ALARM. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. INSULIN PUMP WAS EXPOSED TO MAGNETIC FIELD. 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 9736374 ↗
• MalfunctionJun 25, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP STARTED TO ALARM WITH BUTTON ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 130 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THEY HAD INSULIN PUMP¿S IN THE PAST AND HAD NEVER SEEN THAT ALARM. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD A BLACK DOT SO THE INSULIN PUMP WAS NOT WORKING AND WAS NOT GIVING INSULIN. 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 8730051 ↗
• MalfunctionMar 29, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  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 KEYPAD WAS UNRESPONSIVE. THE CUSTOMER REPORTED THAT THE TIME CLOCK WAS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8463268 ↗
• InjuryJul 26, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND RESERVOIR LIP RING. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 400 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. CUSTOMER WILL RETURN DEVICE FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7724220 ↗
• MalfunctionJan 23, 2018Detachment Of Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BOTTOM OF THE INSULIN PUMP WAS DETACHED AND WOULD NOT STICK BACK IN. THE CUSTOMER'S BLOOD GLUCOSE WAS 206 MG/DL AT THE TIME OF INCIDENT. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7212869 ↗
• InjuryDec 12, 2017Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE OF AROUND 457 MG/DL. PATIENT'S CURRENT BLOOD GLUCOSE VALUE: 228 MG/DL. OTHER BLOOD GLUCOSE VALUES WERE ABOVE 400 MG/DL. NO DELIVERY ALARM WAS ALSO REPORTED. CUSTOMER WAS NEITHER IN EMERGENCE ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCE MEDICAL SERVICES DISPATCHED AS A RESULT OF HIGH BLOOD GLUCOSE VALUES. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA AND TINGLING SENSATION. THE CUSTOMER WAS TREATED WITH CORRECTION BOLUS THROUGH THE PUMP. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 7111140 ↗
• MalfunctionSep 26, 2017Device Displays Incorrect Message

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER SAID THAT THE BLOOD GLUCOSE LEVEL WAS OVER 200MG/DL AND WAS HIGH FOR HER AND WAS NOT ABLE TO TREAT IT. CUSTOMER WAS UNABLE TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVELS. CUSTOMER WAS ADVISED TO REVERT TO BACK UP PLAN PER HEALTHCARE PROFESSIONAL¿S INSTRUCTIONS. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS AND A REPLACEMENT PUMP WILL BE SENT.

  Patient problems: Hyperglycemia

  MAUDE report 6895796 ↗
• InjurySep 21, 2017Break; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 259 MG/DL AT THE TIME OF THE INCIDENT. REPORTEDLY, THE DRIVE SUPPORT CAP WAS STICKING OUT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6884758 ↗
• MalfunctionAug 9, 2017Break

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS TAPED FOR DAMAGE. CUSTOMER CANNOT RECALL THE BLOOD GLUCOSE READING. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THE DAMAGE WAS LOCATED ON THE RESERVOIR TIP. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTHCARE PROVIDER INSTRUCTIONS. INSULIN PUMP WILL BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6778091 ↗
• InjuryJun 28, 2017Device Displays Incorrect Message

  CUSTOMER REPORTED VIA PHONE CALL TO HAVE EXPERIENCED HIGH BLOOD GLUCOSE OF 400 MG/DL. THERE ARE NO SYMPTOMS RELATED TO HIGH BLOOD GLUCOSE WERE OBSERVED. CUSTOMER TREATED WITH MANUAL INJECTION AND DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. CUSTOMER ALSO MENTIONED TO HAVE RECEIVED LOST SENSOR ALERT AND PERFORMED AND COMPLETED TROUBLESHOOTING. CUSTOMER WAS ASSISTED WITH FINDING LOST SENSOR. ADVISED CUSTOMER TO CALL BACK IF ISSUE RECURS. NO PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6673387 ↗

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