MiniMed® 530G MMT-551RNALRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169507937), received between Jul 14, 2017 and Oct 10, 2019 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Crack” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2019No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 360 MG/DL AT THE TIME OF THE INCIDENT AND THERE WAS BLOOD ON SITE. CUSTOMER STATES THAT DAMAGE OCCURRED DUE TO CRACK ON RESERVOIR LIP RING BUT HE DID NOT DROP THE INSULIN PUMP. CUSTOMER ALSO STATES THAT RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. 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: Blood Loss

  MAUDE report 9173895 ↗
• MalfunctionSep 6, 2018Power Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP RECEIVED FAILED BATTERY TEST ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 124 MG/DL. CUSTOMER ALSO REPORTED THAT FAILED BATTERY TEST ALARM REOCCUR WITH EACH NEW BATTERY INSERTED. CUSTOMER REPORTS CONTACTS ARE NOT MISSING OR DAMAGED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7853228 ↗
• InjuryMay 16, 2018Inaccurate Delivery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE OF 50 MG/DL. CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 102 MG/DL.THE CUSTOMER TREATED WITH FOOD. TROUBLESHOOTING WAS DONE FOR LOW BLOOD GLUCOSE. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF LOW BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER OR OVER DELIVERING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS

  Patient problems: Hypoglycemia

  MAUDE report 7517460 ↗
• MalfunctionJan 18, 2018Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PUMP WAS UNDER DELIVERING INSULIN. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS OVER 300 MG/DL AT TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE LEVEL WAS 178 MG/DL. THE CUSTOMER¿S THEY HAD ISSUES WITH PUMP AND HAD HIGH BLOOD GLUCOSE AND WAS TREATED WITH MANUAL INJECTION. THE CUSTOMER ALLEGED INSULIN PUMP WAS UNDER DELIVERING AND THEY HAD BEEN HAVING HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS TO REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS UNTIL REPLACEMENT ARRIVES. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7203941 ↗
• InjuryDec 11, 2017Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 590 MG/DL. HE TOOK 20 UNITS OF INSULIN AND HIS BLOOD GLUCOSE WAS NOT COMING DOWN. THE CUSTOMER ALSO HAD BLOOD GLUCOSE OF 480 MG/DL. CUSTOMER STATED HE TOOK A LONG WALK AND HIS BLOOD GLUCOSE WAS AROUND 270 MG/DL. CUSTOMER STATED HIS SENSOR GLUCOSE WAS READING 400 MG/DL. WHEN THE CUSTOMER GOT HOME AROUND 6 PM, HIS METER SAID IT WAS TOO HIGH TO TEST. CUSTOMER THEN TOOK 12 UNITS OF INSULIN AND AND THEN 8 MORE UNITS OF INSULIN. CUSTOMER'S BLOOD GLUCOSE LAST TIME HE CHECKED WAS 450 MG/DL. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 423 MG/DL. THE CUSTOMER TREATED WITH BOLUS FROM INSULIN PUMP. THE DRIVE SUPPORT CAP WAS NORMAL. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7105318 ↗
• InjuryDec 8, 2017Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZE DUE TO LOW BLOOD GLUCOSE LEVEL 28 MG/DL. THE CUSTOMER¿S HIGH BLOOD GLUCOSE 27 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER¿S HIGH BLOOD GLUCOSE 168 MG/DL AT THE TIME OF CALL. THE CUSTOMER HAD TREATED WITH GLUCOSE TABLETS PRIOR TO HOSPITALIZATION. THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER DECLINED TROUBLESHOOTING. CUSTOMER WAS WEARING THE INSULIN PUMP AT TIME OF HOSPITALIZATION. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7101192 ↗
• InjurySep 1, 2017Break; Crack; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY INSULIN PUMP WAS DAMAGED AND THAT THEY ALSO EXPERIENCED A LOW BLOOD GLUCOSE LEVEL OF 54 MG/DL AFTER THE DAMAGE WAS DISCOVERED. THE CUSTOMER THAT THEY WERE TRYING TO TIGHTEN THE BATTERY CAP WHEN THEY HEARD A CRACK. THE CUSTOMER ALSO MENTIONED THAT THE INSULIN PUMP WENT INTO THRESHOLD SUSPEND. THE CUSTOMER REPORTED TREATING FOR A HIGH BLOOD GLUCOSE OF 188 MG/DL AND 273 MG/DL WITH THE INSULIN PUMP BOLUS. THE CUSTOMER STATED THAT THEIR CURRENT BLOOD GLUCOSE LEVEL DURING THE CALL WAS 58 MG/DL AFTER TREATING WITH GLUCOSE TABS AND PROTEIN MILK SHAKE. TROUBLESHOOTING FOR DAMAGE WAS PERFORMED AND THE BATTERY COMPARTMENT WAS FOUND DAMAGED. 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 BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 6837739 ↗
• MalfunctionAug 28, 2017Crack; Moisture or Humidity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD FLUID UNDER ITS LCD SCREEN. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF INCIDENT IS UNKNOWN. DURING TROUBLESHOOTING THE CUSTOMER STATED THAT THE INSULIN PUMP WAS SITTING ON THE SHELF IN THE BATHROOM DURING HER SHOWER. SHE NOTED A SMALL CRACK IN THE SCREEN WHEN THERE WAS CONDENSATION, BUT THE CRACK DID NOT APPEAR ANYMORE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO HER MEDICALLY PRESCRIBED BACKUP PLAN. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6826144 ↗
• MalfunctionJul 14, 2017Application Interface Becomes Non-Functional Or Program Exits Abnormally

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP WOULD NOT EXIT THE PREPARING TO PRIME SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER MENTIONED THAT THEY HAVE BEEN HAVING HIGH BLOOD GLUCOSE FOR THE PAST FEW DAYS BUT DECLINED TO TROUBLESHOOT FOR THE HIGH READINGS. THE CUSTOMER STATED THAT THEY WERE UNABLE TO COMPLETE A SET CHANGE. THE CUSTOMER WAS ADVISED TO HOLD DOWN THE ACT BUTTON UNTIL RECEIVING A SECOND SERIES OF BEEPS AND/OR NUMBERS APPEAR ON THE DISPLAY. THE CUSTOMER STATED THAT THEY DID NOT RECEIVE THE BEEPS NOR DID THE NUMBERS APPEAR ON THE SCREEN. 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 6714123 ↗

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