MiniMed® 530G MMT-551PNAPRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00643169507296), received between Jun 20, 2017 and Sep 19, 2019 — classified as 17 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (3 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 31 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2019Obstruction of Flow; Obstruction of Flow

  CUSTOMER'S FAMILY REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS OVER 500 MG/DL AT THE TIME OF INCIDENT. CUSTOMER'S FAMILY REPORTED THAT INSULIN PUMP NOT DELIVERING INSULIN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9085659 ↗
• InjurySep 19, 2019No Display/Image; No Apparent Adverse Event; Patient Device Interaction Problem; No Display/Image; No Apparent Adverse Event; Patient Device Interaction Problem

  CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS OVER 500 MG/DL AND LAST WEEK BLOOD GLUCOSE WAS 519 MG/DL. CUSTOMER TREATED WITH INSULIN PUMP AND MANUAL INJECTION. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP WAS NOT WORKING. THE CUSTOMER STATED THAT RESERVOIR COMPARTMENT WAS CRACK AND RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. THE CUSTOMER WAS ADVICE THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVICE TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9085271 ↗
• MalfunctionJul 30, 2019No Display/Image; Mechanical Problem; No Display/Image; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD MOTOR ERROR AND INSULIN PUMP DID NOT WORK AT ALL ANYMORE. 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 8840365 ↗
• MalfunctionMay 3, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A RECURRING NO DELIVERY ALARM FOLLOWED BY MOTOR ERROR ALARM. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 252 MG/DL AND TREATED WITH CORRECTION BOLUS. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS AND THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER COMPLETED TROUBLESHOOTING AND WAS ABLE TO REWIND THE DEVICE. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8576707 ↗
• MalfunctionMar 22, 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 233 MG/DL. THE CUSTOMER REPORTED AN ALARM OCCURRED DURING THE TIME THE BUTTONS STOPPED RESPONDING. IT WAS REPORTED THAT ALL BUTTONS WERE NOT RESPONDING PROPERLY. 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 8443892 ↗
• MalfunctionMar 14, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SCREEN WAS SCRATCHED MAKING IT DIFFICULT TO READ. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8419571 ↗
• MalfunctionJan 31, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND LOUDER DURING REWIND MOTOR AND INSULIN SQUIRTING DURING PRIMING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. PUMP HAS REJECTED NEW BATTERY. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WAS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8292113 ↗
• MalfunctionOct 29, 2018Priming Problem; Priming Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN WAS SQUIRTING OUT DURING PRIMING. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE ESC BUTTON WAS HARDER TO PRESS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8013902 ↗
• MalfunctionOct 26, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD CONSTANT TONE NOT BEEPING AND BUTTON NOT RESPONDING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 90 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. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD MOTOR ERROR AND BATTERY OUT LIMIT ALARM. CUSTOMER STATED THAT THEY WERE CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE THE 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: No Consequences Or Impact To Patient

  MAUDE report 8008205 ↗
• MalfunctionOct 15, 2018Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 59 MG/DL, 55 MG/DL, 90 MG/DL,185 MG /DL 125 MG/DL AND 72 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THEY TOOK BATTERY OUT THE INSULIN PUMP, SCREEN WAS BLANK BUT INSULIN PUMP WAS STILL ALARMING. 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: Hypoglycemia

  MAUDE report 7964574 ↗
• MalfunctionSep 26, 2018Adverse 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 LEVEL OF 447 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7911324 ↗
• MalfunctionJul 31, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7737742 ↗
• MalfunctionJul 30, 2018Power Problem; Power 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 BATTERY LIFE DOES NOT LAST LONG, HAD FAILED BATTERY TEST ALARM, AND LOUDER REWIND PROCESS. CUSTOMER DECLINED TROUBLESHOOTING. INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7730309 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE ALARM OCCURRED WHILE CHANGING THE RESERVOIR. CUSTOMER SAID BLOOD GLUCOSE AT THE TIME OF INCIDENT 140 MG/DL. CUSTOMER STATED THE DRIVE SUPPORT CAP WAS LOOSE. THE CUSTOMER IS ON PEN SINCE SATURDAY. THE INSULIN PUMP WILL BE RETURNING FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7669070 ↗
• InjuryJul 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 47 TO 390 MG/DL AT THE TIME OF THE INCIDENT. TROUBLESHOOTING WAS DECLINED BY THE CUSTOMER. PRODUCT WILL BE RETURNED DEVICE FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 7657703 ↗
• InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE WAS 502 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7486927 ↗
• InjuryJan 11, 2018Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD LOW BLOOD GLUCOSE VALUE. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 42MG/DL. CUSTOMER TREATED WITH ORANGE JUICE, CRACKERS AND PEANUT BUTTER. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7183496 ↗
• InjuryDec 14, 2017Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 424 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER REPORTED THAT HE RAN OUT OF INSULIN AND HAD HIGH BLOOD GLUCOSE LEVEL AND THEN CHANGED RESERVOIR AND THE BLOOD GLUCOSE LEVEL WENT DOWN TO 361 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7120032 ↗
• InjuryOct 3, 2017Dent in Material; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PATIENT¿S BLOOD GLUCOSE WAS LOW. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 43 MG/DL AT THE TIME OF THE INCIDENT. THE PATIENT'S CURRENT BLOOD GLUCOSE WAS 197 MG/DL. THE CUSTOMER REPORTED THAT SHE STARTED HALLUCINATING AND STARTED SEEING LIGHTERS, AND PLAYING WITH THE CURTAINS. THEY ASKED FOR HER DAUGHTER AND THEY CHECKED HER BLOOD GLUCOSE AND IT WAS 43 MG/DL AND GAVE HER MILK. EARLIER IT WAS 57 MG/DL. THIS WEEK SHE HAS BEEN LOW IN 60'S MG/DL AND LAST NIGHT HER BLOOD GLUCOSE WAS 63 MG/DL, TODAY SHE WAS LOW AGAIN ABOUT 67 MG/DL. THE PATIENT HAS TREATED WITH FOOD. THE DRIVE SUPPORT CAP APPEARS NORMAL (SLIGHTLY INDENTED). THE PUMP ALSO HAD A BAD BATTERY ALARM. IT DID NOT ALARM AFTER REPLACING NEW BATTERY. THE CUSTOMER DOES BELIEVE PUMP WAS OVER DELIVERING INSULIN. 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: Hypoglycemia

  MAUDE report 6912754 ↗
• InjuryOct 3, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 120 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD A RECURRING MOTOR ERROR ALARM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. CUSTOMER ALSO REPORTED TO HAVE RECEIVED A MOTOR POSITION ENCODER ERROR. CUSTOMER ALSO REPORTED TO HAVE EXPERIENCED A LOW BLOOD GLUCOSE OF 51 MG/DL AND TREATED WITH FOOD. NO LOW BLOOD GLUCOSE TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 6911852 ↗
• InjurySep 22, 2017Bent

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BLOOD GLUCOSE LEVEL IS HIGH WHICH IS OVER 600 MG/DL. CUSTOMER STATED HAS ANOTHER BENT CANNULA AND NEEDS TO REPORT IT. CUSTOMER STATED HAS ANOTHER BENT CANNULA. TROUBLESHOOTING ASSISTED FOR BENT CANNULA. CUSTOMER REPORTED THAT THE INFUSION SET CANNULA BENT. WHEN CUSTOMER WOKE UP AND BLOOD GLUCOSE WAS OVER 600 MG/DL. CUSTOMER INDICATED THEY UNDERSTOOD THE RETURN POLICY. CUSTOMER REPLACED THE INFUSION SET AND SENDING CANISTER, ENVELOPE FOR RETURN OF SET. CUSTOMER IS USING THE QUICKSET. CUSTOMER STATED THAT BLOOD GLUCOSE WAS OVER 600 MG/DL AND SHE GAVE A SHOT WITH INSULIN. TROUBLESHOOTING WAS OFFERED FOR HIGH AND CUSTOMER DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6887708 ↗
• InjuryAug 17, 2017Sticking; Device Inoperable; Moisture or Humidity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ESC BUTTON WAS NOT WORKING. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 406 MG/DL DURING THE TIME OF INCIDENT CAUSED BY SITE BEING PULLED OUT WHILE SLEEPING. CUSTOMER STATES HE WAS PRIMING PUMP AND IT WAS STUCK ON THIS SETTING BECAUSE HE COULD NOT HIT ESC TO BE DONE. CUSTOMER WAS NOT SURE HOW THE BUTTON STOP WORKING HE MENTION COULD BE EXPOSED TO MOISTURE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP- HCP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6802510 ↗
• InjuryAug 11, 2017Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE ESC BUTTON WAS NOT RESPONSIVE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 406 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6790479 ↗
• MalfunctionAug 10, 2017Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL TO HAVE HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS OVER 400 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING. CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6786722 ↗
• MalfunctionAug 3, 2017Device Displays Incorrect Message

  CUSTOMER CALLED TO REPORT THAT THE INSULIN PUMP EXPERIENCED AN UNEXPECTED RESTART ALARM DURING NORMAL USE. CUSTOMER'S BLOOD GLUCOSE LEVELS WERE NOT INCLUDED IN THE REPORT. TROUBLESHOOTING WAS DONE. PRODUCT IS EXPECTED TO RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6765870 ↗

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