MiniMed™ Reservoir MMT-326ARecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 20763000273334), received between Jan 23, 2020 and Aug 10, 2020 — classified as 11 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (14 reports).

1 other recall cover devices cleared under the same FDA submission (K001828, K032005); 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2020Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER CURRENT BLOOD GLUCOSE LEVEL WAS 600 MG/DL. CUSTOMER OTHER BLOOD GLUCOSE WAS 522 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THE SITE FILLS ITCHY, SITE FROM LAST NIGHT. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION AS WELL BOLUS FOR HIGH BLOOD GLUCOSE. CUSTOMER ATE SOME PIZZA LAST NIGHT, SHE BLOUSED, BLOOD GLUCOSE DID NOT GO BACK DOWN. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THEY DID ALLEGING INSULIN PUMP FOR UNDER DELIVERY BECAUSE SHE BOLUSES AND KEEPS GOING HIGH. CUSTOMER STATED THAT THEY DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED INSULIN EXITED AT THE QUICK RELEASE. CUSTOMER STATES THE CANNULA WAS NOT BENT. THE INSULIN PUMP WILL BE AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Itching Sensation

  MAUDE report 10383866 ↗
• MalfunctionAug 10, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT RESERVOIR HAD AIR BUBBLE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10383852 ↗
• MalfunctionAug 6, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED AN INSULIN FLOW BLOCKED ALARM. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 20.0 MMOL/L. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS. NO PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10372041 ↗
• MalfunctionAug 3, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR HAD AIR BUBBLE. CUSTOMER REPORTED THAT THE FILL RESERVOIR WAS CORRECT. NO HARM REQUIRING MEDICAL INTERVENTIONS WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10354639 ↗
• InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 400 MG/DL. IT WAS UNKNOWN HOW THE CUSTOMER TREATED FOR THEIR HIGH BLOOD GLUCOSE NO FURTHER DETAILS GIVEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10342345 ↗
• MalfunctionJul 15, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT AIR BUBBLES IN RESERVOIR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT SIZE OF AIR BUBBLE 2 CM. CUSTOMER STORED INSULIN BY ROOM TEMPERATURE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10275159 ↗
• MalfunctionJul 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED VIA PHONE CALL RESERVOIR ANOMALY. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ADVISED THE RESERVOIR LEAKED AT THE INFUSION SET TUBING CONNECTION. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10256121 ↗
• InjuryJul 7, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCE HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 403 MG/DL AT THE TIME OF INCIDENT. CUSTOMER HAD USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT AND AUTO MODE WAS ACTIVE. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL. CUSTOMER ALLEGING POSSIBLE INSULIN PUMP UNDER DELIVERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10243157 ↗
• MalfunctionJun 26, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED INSULIN FLOW BLOCK ALARM. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR INSULIN FLOW BLOCK ALARM. CUSTOMER STATED THAT THEY CHANGED RESERVOIR AND RAN LOAD RESERVOIR OR FILL TUBING TO AT LEAST 5.0U FOR INSULIN INSULIN FLOW BLOCK ALARM. INSULIN FLOW BLOCK ALARM WAS RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10199622 ↗
• InjuryJun 19, 2020Obstruction of Flow; Improper Flow or Infusion; No Apparent Adverse Event; Obstruction of Flow; Improper Flow or Infusion; No Apparent Adverse Event

  IT WAS REPORTED THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 33 MMOL/L. CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED RESERVOIR HAD AIR BUBBLE AND ALSO HAD INSULIN FLOW BLOCKED ALARM. CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10172693 ↗
• InjuryJun 19, 2020Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; No Apparent Adverse Event

  IT WAS REPORTED THAT THE THEY WERE EXPERIENCING LOW BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 2.7 MMOL/L. CUSTOMER WAS TREATED WITH FOOD. CUSTOMER STATED THEY ALLEGED INSULIN PUMP WAS OVER DELIVERING. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. TROUBLESHOOTING WAS PERFORMED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10172648 ↗
• MalfunctionJun 17, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR HAD AIR BUBBLES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10161384 ↗
• InjuryJun 10, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALLEGING POSSIBLE UNDER DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS 1.6 MMOL/L AND 23 MMOL/L. CUSTOMER STATED REASON FOR UNDER DELIVERY WAS BLOOD GLUCOSE WAS NOT CAME DOWN. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10136701 ↗
• InjuryJun 4, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE 205 MG/DL, 61 MG/DL, 558 MG/DL TO 400 MG/DL. THE CUSTOMER HAD BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF HIGH BLOOD GLUCOSE LEVEL EVENT. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE LEVEL WITH BOLUS. THE CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICES DISPATCHED AS A RESULT OF HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER ALLEGED THE INSULIN PUMP FOR UNDER DELIVERY SHE WAS RUNNING HIGH. THE DRIVE SUPPORT CAP APPEARED NORMAL. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST AND HIGH PRESSURE TEST. THE CUSTOMER NOTICED TINY AIR BUBBLES IN THE RESERVOIR WHILE TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10117430 ↗
• MalfunctionMay 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR WAS LEAKING ON THE TOP OF THE RESERVOIR ON THE NEEDLE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10085743 ↗
• MalfunctionMay 18, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR HAD AIR BUBBLE ANOMALY. CUSTOMER STATED THAT LOT OF BUBBLES FORM WHEN FILLING RESERVOIRS, WHILE LEADING TO FILLING WAS TAKEN A LOT OF TIME. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10064801 ↗
• InjuryMay 15, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE AS WELL AS INSULIN PUMP HAD AN UNDER DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 25 MMOL/L AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE BLOOD GLUCOSE VALUE WAS RISES AFTER ONE HOUR OF INSULIN AND THE VALUE WAS 27 MMOL/L. THE CUSTOMER USED THE INSULIN PUMP AND MANUAL INJECTIONS TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. CUSTOMER WAS ALLEGING THE INSULIN PUMP FOR UNDER DELIVERY BECAUSE THE BLOOD GLUCOSE REMAINS HIGH AFTER BOLUSING AND CHANGING SET. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10060620 ↗
• MalfunctionMay 15, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALLEGED OVER DELIVERY AS FILL CANNULA WAS RECORDED IN THE DAILY HISTORY. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR LOW BLOOD GLUCOSE LEVEL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE LEVEL. CUSTOMER WAS TREATED WITH GLUCOSE TABLETS FOR LOW BLOOD GLUCOSE LEVEL. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICE DISPATCHED AS A RESULT OF LOW BLOOD GLUCOSE LEVEL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10060387 ↗
• MalfunctionMay 7, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE WERE AIR BUBBLES IN RESERVOIR AND TUBING. CUSTOMER STATED THAT THE SIZE OF AIR BUBBLE WAS BOTH SMALLER AND BIGGER. CUSTOMER CHANGED RESERVOIR AND THERE WAS NEITHER LEAKS NOR AIR BUBBLES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10031614 ↗
• MalfunctionApr 27, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR HAD AN AIR BUBBLE ANOMALY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10000516 ↗
• MalfunctionApr 25, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR HAD AIR BUBBLES. APPROXIMATE SIZE OF AIR BUBBLES WERE 1 CENTIMETRE. TROUBLESHOOTING WAS NOT COMPLETED. RESERVOIR WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9999092 ↗
• MalfunctionApr 24, 2020Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR HAD AIR BUBBLES. CUSTOMER BLOOD GLUCOSE READING AT THE TIME OF THE INCIDENT UNKNOWN. TROUBLESHOOTING WAS NOT COMPLETED. RESERVOIR WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9994967 ↗
• MalfunctionApr 15, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR HAD AIR BUBBLES. THE SIZE OF THE AIR BUBBLES WERE 2 MM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS NOT COMPLETED. RESERVOIR WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9961154 ↗
• InjuryApr 14, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  CUSTOMER CALLED AND REPORTED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE ON (B)(6) 2020 WITH BLOOD GLUCOSE OF 486 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER USED AN INSULIN PEN TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER ALLEGED PUMP UNDER DELIVERY. TROUBLESHOOTING WAS NOT COMPLETED BUT THE PUMP FAILED A SELF TEST WITH A HARDWARE LOW LEVEL FAILURES ALARM. THE CUSTOMER USES A COMPETITOR'S SENSOR SYSTEM. THE CUSTOMER MENTIONED PUMP COSMETIC DAMAGE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9959728 ↗
• MalfunctionApr 14, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR HAD AIR BUBBLES. THE SIZE OF THE AIR BUBBLES IS 2 MM. TROUBLESHOOTING WAS NOT COMPLETED. THE RESERVOIR WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9956393 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001828, K032005. One submission often covers many models, so check the product and lot details in each record.

• Z-1986-2013 · Jul 3, 2013 · Terminated
  Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Me