MiniMed® 530G MMT-551PNASRecalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00643169507302), received between Jun 5, 2017 and Mar 26, 2020 — classified as 2 deaths, 31 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (15 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 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  THE CUSTOMER CALLED AND REPORTED THAT THEIR INSULIN PUMP WAS SLOWER TO REWIND AND THE BUTTONS WERE LESS RESPONSIVE. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9886954 ↗
• MalfunctionMar 4, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS CRACKED AND DAMAGED AT RESERVOIR OPENING. THE CUSTOMER STATED THAT THE RESERVOIR DID NOT LOCKED INTO PLACE WHEN INSERTED INTO INSULIN PUMP. 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 9784957 ↗
• MalfunctionDec 23, 2019Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Priming Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THERE WAS SLIGHT DELAY IN BUTTON PUSHES TO PRIME, ALSO DISPLAY SCREEN WAS SCRATCHED UP BUT CAN STILL SEE THROUGH IT, BACK LIGHT WAS DIM AND WAS LITTLE NOISIER TO REWIND. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9511215 ↗
• MalfunctionDec 4, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; 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 BUTTON WAS STICKING PUMP WAS SKIPPING AFTER HITTING THE BUTTON. IT WAS REPORTED THAT THE INSULIN PUMP WAS EITHER OVER RESPONDING OR NOT RESPONDING AT ALL AND PUMP REWIND HAD SLOWED DOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9408717 ↗
• MalfunctionDec 3, 2019Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MOTOR ERROR. 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 9400774 ↗
• MalfunctionNov 12, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE THAT THE BUTTONS WERE UNRESPONSIVE AND HARD TO PRESS. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP WAS LOUDER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9308034 ↗
• MalfunctionOct 9, 2019Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PLASTIC ON RESERVOIR WAS CHIP OFF. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM DURING PRIMING PROCESS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9170456 ↗
• MalfunctionOct 3, 2019Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MULTIPLE UNEXPECTED RESTART AFTER BATTERY CHANGE. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE ABLE TO REWIND THE INSULIN PUMP. ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. THE CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE PUMP 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 9149649 ↗
• InjurySep 24, 2019Mechanical Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE AND INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 472 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN PUMP. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. CUSTOMER REPORTED THE DRIVE SUPPORT CAP APPEARED NORMAL (SLIGHTLY INDENTED). INSULIN PUMP HAD BEEN EXPOSED TO AN X-RAY. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. 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 INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS

  Patient problems: Hyperglycemia

  MAUDE report 9108464 ↗
• MalfunctionAug 26, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE NO LONGER WORKING OF INSULIN PUMP. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 127 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTED THAT THE TIME WAS ADVANCING. THE CUSTOMER WAS ADVISED TO REPLACE AND 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 8929447 ↗
• MalfunctionAug 23, 2019Device Alarm System; Patient Device Interaction Problem; Device Alarm System; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD LOUDER VIBRATIONS AND HAD CRACK ON CASING. 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 8925156 ↗
• InjuryAug 21, 2019Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 410 MG/DL. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER ALSO STATED THAT THEY DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER STATED THAT THEY RECEIVED NO DELIVERY ALERT. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER STATES THE INSULIN EXITED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8915041 ↗
• MalfunctionAug 13, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTONS ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED SOMETIME BUTTONS WERE NEED TO PRESS TWICE. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS LOUDER DURING REWIND. CUSTOMER ASSISTED TO TROUBLESHOOT FOR UNRESPONSIVE BUTTONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8887010 ↗
• MalfunctionJul 26, 2019Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR THE ALARM. THE CUSTOMER STATED THAT THEY WERE ABLE TO REWIND THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8829829 ↗
• MalfunctionJul 19, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER ALLEGES INSULIN PUMP WAS OVER DELIVERING. THE CUSTOMER¿S LOW BLOOD GLUCOSE WAS 80 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS TREATED WITH FOOD AND GLUCOSE TABLETS. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8807243 ↗
• MalfunctionJul 10, 2019Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Battery Problem; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Battery Problem; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD STICKY BUTTONS AND REJECTS NEW BATTERY. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATE THAT INSULIN PUMP HAD SCRATCHES ON THE SCREEN IN BRIGHT LIGHT HAD TO TILT TO READ THE VALUES. THE CUSTOMER ALSO STATE THAT THE BACK LIGHT WAS NOT AS BRIGHT AS PREVIOUS AND INSULIN PUMP REWINDS MORE THAN ONCE AND ALSO STATE THAT THE INSULIN PUMP LOST SETTING DURING A BATTERY CHANGE LESS THAN FIVE MINUTES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8775003 ↗
• MalfunctionJul 9, 2019Obstruction of Flow; Date/Time-Related Software Problem; Patient Device Interaction Problem; Obstruction of Flow; Date/Time-Related Software Problem; Patient Device Interaction Problem

  CUSTOMER THE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP¿S CLOCK RUNNING SLOW ALSO NO DELIVERY ALARM DURING PRIMING PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE TRANSMITTER DECLINED BATTERY LIFE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8770418 ↗
• MalfunctionJul 2, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP SCREEN WAS SCRATCHED AND THEY WERE ABLE TO SEE THE SCREEN BUT WAS LITTLE HARD TO READ THE SCREEN. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8752311 ↗
• MalfunctionJun 27, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP DID NOT REWIND. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 111 MG/DL AT THE TIME OF THE INCIDENT. 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 8742506 ↗
• MalfunctionMay 27, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 136 MG/DL. THE CUSTOMER REPORTED THAT THE RESERVOIR COMPARTMENT WAS NOT STAYING IN PLACE. THE CUSTOMER REPORTED THAT THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE. THE 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 BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8643940 ↗
• MalfunctionApr 23, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ENCODER POSITION ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 190 MG/DL. THE CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER ADVISE TO DISCONTINUE USE OF THE PUMP AND RECOMMENDED CUSTOMER REFER TO BACK UP PLAN, PER HCP INSTRUCTIONS. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8538537 ↗
• MalfunctionApr 22, 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¿S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE DOWN ARROW BUTTON DOES NOT WORK WELL WHICH MADE IT DIFFICULT FOR DOSING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8534540 ↗
• MalfunctionMar 29, 2019Display or Visual Feedback Problem; Obstruction of Flow; Patient Device Interaction Problem; Display or Visual Feedback Problem; Obstruction of Flow; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD MULTIPLE ISSUES WITH INSULIN PUMP. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS, SOMETIMES CUSTOMER DISCONNECTS AT SITE, SOMETIMES CUSTOMER CHANGES OUT SITE, DID NOT ALWAYS WORK AND SOMETIMES INSULIN PUMP NEEDS TO BE RESTARTED AND INSULIN PUMP HAD SCRATCHES WHICH CAN AFFECT ABILITY TO READ SCREEN WHEN IT WAS DARK. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8463089 ↗
• MalfunctionMar 12, 2019Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER WAS NOT ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8411236 ↗
• MalfunctionFeb 14, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DAMAGED. CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THE TOP OF THE RESERVOIR COMPARTMENT WAS CRACK, PLASTIC WAS MISSING AND ABLE TO LOCK IN PLACE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8338275 ↗

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