MiniMed® 530G MMT-551PNABRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00643169507265), received between Jun 3, 2017 and Oct 20, 2019 — classified as 18 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (8 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  CUSTOMER CALLED AND REPORTED THAT THEY EXPERIENCED LOW BLOOD GLUCOSE WITH BLOOD GLUCOSE OF 54 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER USED FOOD TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER REPORTED THE PUMP WAS OVER DELIVERING. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9211803 ↗
• MalfunctionApr 22, 2019Mechanical Problem; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD PRIME ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE PUMP SHOOTS INSULIN OUT OF INFUSION SET DURING PRIMING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8534709 ↗
• MalfunctionMar 19, 2019Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Power Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Power 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. CUSTOMER STATED THAT THE INSULIN PUMP HAD DIMINISHED BATTERY LIFE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8431449 ↗
• MalfunctionMar 14, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 105 MG/DL AT THE TIME OF THE INCIDENT. PIECE MISSING FROM THE RESERVOIR COMPARTMENT. THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO PUMP. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WAS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8423421 ↗
• MalfunctionMar 12, 2019Device Difficult to Program or Calibrate; Battery Problem; Device Difficult to Program or Calibrate; Battery Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE ACT BUTTONS HAD TO BE PRESSED HARD AND WAS NOT DOING WHAT THEY ARE SUPPOSED TO BE DOING AND INSULIN PUMP FREQUENTLY SQUIRTS INSULIN WHEN PRIMING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS DECLINED TO TROUBLESHOOT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8410919 ↗
• InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVEL WAS 450 MG/DL. CUSTOMER'S OTHER BLOOD GLUCOSE LEVEL WAS 350,140 ,150MG/DL. TROUBLESHOOTING WAS PERFORMED FOR AIR BUBBLE. THE PRODUCT WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8398202 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE AND HAD PASSED OUT. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 7844467 ↗
• MalfunctionAug 7, 2018Power Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED OFF NO POWER. THE BLOOD GLUCOSE VALUE LEVEL WAS 354 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THEY DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO OFF NO POWER ALARM. TROUBLESHOOTING WAS COMPLETED. CUSTOMER WAS ADVISED TO MONITOR. THE CUSTOMER WILL NOT RETURN THE PRODUCT.

  Patient problems: Hyperglycemia

  MAUDE report 7759974 ↗
• MalfunctionJun 19, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD AN UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY HAD CHANGED THE BATTERY AND RECEIVED AN UNEXPECTED RESTART ALARM. THE TROUBLESHOOTING WAS PERFORMED (NOT PERTAINING TO PUMP RECENTLY STORED OR NOT IN USE FOR EXTENDED PERIOD OF TIME) AND RECEIVING ANOTHER UNEXPECTED RESTART ALARM AFTER A BATTERY CHANGE. THE CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO MONITOR THE PUMP AND CALL IF ISSUES RECUR. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7613951 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE WAS 488 MG/DL AT THE TIME OF INCIDENT. THE CURRENT BLOOD GLUCOSE LEVEL WAS 471 MG/DL. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS IRRITATED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7571069 ↗
• MalfunctionJun 3, 2018Device Operates Differently Than Expected; Infusion or Flow Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN WAS SQUIRTING OUT DURING MANUAL PROCESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 140 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATES THEY DID NOT RECEIVE SECOND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7564170 ↗
• InjuryMay 31, 2018Loss of Power; Insufficient Flow or Under Infusion; Device Displays Incorrect Message

  CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF OVER 700MG/DL, DIABETIC KETOACIDOSIS, MINOR HEART ATTACK AND KIDNEY FAILURE ON (B)(6) 2018. CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 215MG/DL. CUSTOMER HAD SYMPTOMS LIKE EXHAUSTION, LOSS OF CONSCIOUSNESS. CUSTOMER WAS WEARING INSULIN PUMP AT TIME OF HOSPITALIZATION. CUSTOMER ALLEGED FOR POSSIBLE UNDER DELIVERY OF INSULIN PUMP BUT DRIVE SUPPORT CAP WAS NORMAL AND INSULIN EXITED AT QUICK RELEASE. CUSTOMER ALSO REPORTED THAT INSULIN PUMP KEEPS ALARMING AND SHUTTING OFF WITH NEW BATTERIES. CUSTOMER PERFORMED TROUBLESHOOT BUT DISPLAY DID RETURN. INSULIN PUMP WILL BE RETURN FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 7555913 ↗
• InjuryMay 7, 2018Defective Component; Invalid Sensing

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE AROUND (B)(6) 2018 WITH BLOOD GLUCOSE OF 23 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 126 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER USED SUGAR, FOOD, AND CANDY TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS COLLAPSING AND LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED. THE CUSTOMER MENTIONED SENSOR GLUCOSE VERSUS BLOOD GLUCOSE DIFFERENCES. THE CUSTOMER STATED THAT THE TRANSMITTER WAS NOT WORKING PROPERLY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7490585 ↗
• MalfunctionApr 27, 2018Crack; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 116 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE TOP OF THE RESERVOIR WAS CRACKED. THE CUSTOMER STATED THAT THE PUMP SQUIRTED OUT INSULIN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND WAS ADVISED TO REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7467687 ↗
• InjuryApr 12, 2018Excess Flow or Over-Infusion

  CUSTOMER CALLED AND REPORTED THAT THEY EXPERIENCED LOW BLOOD GLUCOSE, WITH BLOOD GLUCOSE OF 40 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 68 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER USED CARBS TO TREAT. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. BASED ON CUSTOMER REPORT PROCEEDING IN TROUBLESHOOTING PER CUSTOMER ALLEGING POSSIBLE PUMP OVER DELIVERY. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER BELIEVES THE PUMP IS OVER DELIVERING. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7424295 ↗
• MalfunctionApr 6, 2018Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP WOULD NOT EXIT THE PREPARING FOR PRIME LOOP AND INSULIN WAS SQUIRTING OUT DURING THE PRIME PROCESS. THE CUSTOMER¿S BLOOD GLUCOSE WAS 88 MG/DL. THE CUSTOMER WAS ASSISTED WITH THE TROUBLESHOOTING. 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 7402013 ↗
• InjuryMar 23, 2018Crack

  THE CUSTOMER REPORTED VIA PHONE CALL THAT PUMP HAD CRACK ON THE SIDE OF THE RESERVOIR AND EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 307 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7368318 ↗
• InjuryMar 13, 2018Nonstandard Device

  CUSTOMER REPORTED VIA PHONE CALL OF EXPERIENCING LOW BLOOD GLUCOSE OF 24 MG/DL AFTER CHANGING INFUSION SET. CUSTOMER WAS FOUND BY DAUGHTER BARELY RESPONSIVE AND WAS TREATED WITH SODA. CUSTOMER BELIEVED THAT LOW BLOOD GLUCOSE WAS DUE TO RECALLED INFUSION SET. INSULIN PUMP WOULD NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7336232 ↗
• InjuryMar 8, 2018Insufficient Device Problem Information

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 26 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS GIVEN FOOD AND DRINKS TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP DURING THE INCIDENT, WITHIN LESS THAN 48 HOURS. TROUBLESHOOTING WAS NOT COMPLETED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7325475 ↗
• MalfunctionJan 12, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 236 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED MOTOR ERROR WHILE THEY WERE SLEEPING. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP LOOSE. 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 7188606 ↗
• MalfunctionJan 5, 2018Air Leak; Insufficient Flow or Under Infusion

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE VALUE. CUSTOMER¿S BLOOD GLUCOSE VALUE AT TIME OF INCIDENT WAS 347 MG/DL AND CURRENT BLOOD GLUCOSE VALUE WAS 75 MG/DL. CUSTOMER TREATED IT MANUALLY. CUSTOMER ALLEGED THE INSULIN PUMP OF UNDER DELIVERY. CUSTOMER ALSO MENTIONED ABOUT LEAK IN THE RESERVOIR PAST FIRST O-RING AND AIR BUBBLES IN THE TUBING. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7169032 ↗
• InjuryDec 28, 2017Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A LOW BLOOD GLUCOSE VALUE OF 42 MG/DL. PATIENT'S CURRENT BLOOD GLUCOSE VALUE: 106MG/DL. LOW BLOOD GLUCOSE LEVEL TROUBLESHOOTING WAS DECLINED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7152803 ↗
• InjurySep 6, 2017Insufficient Device Problem Information

  CUSTOMER CALLED AND REPORTED THAT THEY GOT HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2017 WITH BLOOD GLUCOSE OF 33 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS IN A CAR ACCIDENT AT THE TIME OF THE LOW SO THE POLICE MOST LIKELY CALLED THE PARAMEDICS, WHO FOUND THEM AT 22 MG/DL. THE CUSTOMER WAS GIVEN GLUCOSE TO TREAT. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE CUSTOMER HAD NOT EATEN BEFORE THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 6847384 ↗
• InjurySep 1, 2017Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 590 MG/DL. NO FURTHER DETAILS ARE GIVEN. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. DECLINE TROUBLE SHOOTING FOR HIGH BLOOD GLUCOSE.

  Patient problems: Hyperglycemia

  MAUDE report 6839721 ↗
• MalfunctionAug 22, 2017Device Displays Incorrect Message

  CUSTOMER CALLED TO REPORT THAT THE INSULIN PUMP ALARMED BATTERY OUT LIMIT. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE INCIDENT WAS NOT INCLUDED IN THE REPORT. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE OBSERVED. CUSTOMER WAS ADVISED TO BE SENT A REPLACEMENT BATTERY CAP. PRODUCT IS NOT EXPECTED TO RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6810822 ↗

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