MiniMed Reservoir MMT-326A (UDI 00643169771437)Recalls & reported problems

Summary

The FDA's MAUDE database contains 762 adverse event reports that list this exact device (DI 00643169771437), received between May 26, 2017 and Aug 5, 2020 — classified as 1 death, 310 injuries, 451 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (157 reports).

1 other recall cover devices cleared under the same FDA submission (K001828); 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 762 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ALL OF THE CUSTOMER WAS UNSCREW THE PLUNGER THE ENTIRE BACK OF THE RESERVOIR AND ALL OF THE INSULIN SPILLED OUT. CUSTOMER STATED THAT THERE WAS NO DAMAGE TO THE RESERVOIR. CUSTOMER STATED THAT THE O RINGS WERE INTACT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10366000 ↗
• InjuryJul 29, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE VALUE WAS 167 MG/DL AND OTHER BLOOD GLUCOSE VALUE WAS OVER 500 MG/DL. CUSTOMER REPORTED THAT THEY DID ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. IT WAS UNKNOWN THAT AUTO MODE FEATURE WAS ACTIVE OR NOT AT THE TIME OF EVENT.¿ CUSTOMER REPORTED THAT THERE WAS CRACKED AT THE BOTTOM OF INSULIN PUMP. CUSTOMER STATED THE INSULIN PUMP HAD COSMETIC DAMAGE. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10336735 ↗
• InjuryJul 28, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HYPERGLYCEMIA AND INSULIN PUMP WAS UNDER DELIVERING INSULIN. BLOOD GLUCOSE LEVEL WAS 483 MG/DL. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED THEIR BLOOD GLUCOSE WITH INSULIN INJECTIONS. CUSTOMER ALLEGED INSULIN PUMP FOR POSSIBLE UNDER DELIVERY BECAUSE BLOOD GLUCOSE WAS NOT COMING DOWN. INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10330992 ↗
• InjuryJul 22, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE 170 MG/DL SOMETHING LAST NIGHT AND AN HOUR LATER WITHOUT A CORRECTION, IT WAS 60 MG/DL, CURRENT BLOOD GLUCOSE LEVEL WAS 74 MG/DL AND 40 MG/DL. THE CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER TREATED LOW BLOOD GLUCOSE LEVEL WITH FOOD AND GLUCOSE TABLET. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICES DISPATCHED AS A RESULT OF LOW BLOOD GLUCOSE. THE CUSTOMER ALLEGED THE INSULIN PUMP FOR OVER DELIVERY. THE INSULIN PUMP WILL BE RETURNED AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10306945 ↗
• MalfunctionJul 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR HAD LEAK. 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 10300762 ↗
• InjuryJul 20, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 400 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER ALLEGE INSULIN PUMP WAS UNDER DELIVERING. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10294695 ↗
• MalfunctionJul 17, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER NOTICED AIR BUBBLE IN THE RESERVOIR. THE APPROXIMATE SIZE OF THE AIR BUBBLE WAS 1.5 CM. NO HARM REQUIRING MEDICAL INTERVENTION WAS NOTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10287972 ↗
• InjuryJul 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 THEY HAD A HIGH BLOOD GLUCOSE VALUE OF 30 MMOL/L. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER ALLEGING POSSIBLE INSULIN PUMP UNDER DELIVERY. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA AND VOMITING AND BLURRED VISION. THE CUSTOMER WAS TREATED WITH SYRINGE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Nausea; Vomiting

  MAUDE report 10256292 ↗
• InjuryJul 1, 2020Insufficient Flow or Under Infusion; Improper Flow or Infusion; Insufficient Flow or Under Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2020 WITH BLOOD GLUCOSE OF 219 MG/DL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED WITH INJECTIONS. CUSTOMER STATED THEY CONTACT THEIR HEALTH CARE PROFESSIONAL REGARDING HIGH BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DID ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER STATED RESERVOIR HAD AIR BUBBLES NOTICED DURING THERAPY. THE INSULIN PUMP WILL AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10217114 ↗
• InjuryJun 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL AND RESERVOIR WAS LEAK. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 410 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10210869 ↗
• InjuryJun 24, 2020Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSULIN PUMP DID NOT DELIVER THE INSULIN. THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S HIGH BLOOD GLUCOSE WAS 23 MMOL/L. THE CUSTOMER WAS TREATED WITH SYRINGES. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER DID NOT WISH TO CONTINUE TROUBLESHOOTING. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD CRACKED RETAINER RING AND RESERVOIR WAS ABLE TO LOCK IN PLACE. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Nausea

  MAUDE report 10187896 ↗
• MalfunctionJun 24, 2020Fluid/Blood Leak; Patient Device Interaction Problem; Fluid/Blood Leak; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR IS LEAKING AT O- RINGS. CUSTOMER STATED THAT NO CRACK WAS FOUND. ALL COMPONENTS WAS PRESENT. THERE WAS NO AIR BUBBLE IN RESERVOIR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10187274 ↗
• InjuryJun 22, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED VIA CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 501 MG/DL. CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER EXPERIENCED BLOOD GLUCOSE LEVELS OF 449, 375, 306 AND 72 MG/DL. CUSTOMER STATED THAT THE RESERVOIR WAS LEAKING. CUSTOMER REPORTS O-RING INSIDE LIP OF RESERVOIR COMPARTMENT WAS NOT MISSING. CUSTOMER STATES THERE WERE NO CRACKS IN THE PUMP. CUSTOMER DID SELF TEST AND IT WAS PASSED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10178211 ↗
• InjuryJun 18, 2020Excess Flow or Over-Infusion; No Apparent Adverse Event; Excess Flow or Over-Infusion; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2020 WITH BLOOD GLUCOSE OF 40 MG/DL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. THE CUSTOMER WAS TREATED WITH FOOD. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. THE CUSTOMER REPORTED THAT THEY DID BELIEVE INSULIN PUMP WAS OVER-DELIVERING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10166326 ↗
• InjuryJun 16, 2020Insufficient Flow or Under Infusion; Obstruction of Flow; No Apparent Adverse Event; Insufficient Flow or Under Infusion; Obstruction of Flow; No Apparent Adverse Event

  IT WAS REPORTED THAT CUSTOMER WAS ADMITTED TO THE HOSPITAL DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2020 WITH BLOOD GLUCOSE OF OVER 30 MMOL/L AND THEY ALLEGED INSULIN PUMP WAS UNDER DELIVERING INSULIN DUE TO CUSTOMER TRIED TO DOUBLE INSULIN DOSE BUT STILL BLOOD GLUCOSE NOT CAME DOWN. CUSTOMER HAD CONTACTED THEIR HEALTHCARE PROFESSIONAL REGARDING HIGH BLOOD GLUCOSE. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ADMITTED TO HOSPITAL FOR 21 DAYS. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10160877 ↗
• MalfunctionJun 16, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS OVER DELIVERING. THE CUSTOMER STATED THEY DID NOT TREAT THE ENSUING LOW, BUT ALLOWED THE PUMP IN AUTO MODE TO ADJUST THEIR BASAL RATES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10159168 ↗
• InjuryJun 8, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WERE EXPERIENCING LOW BLOOD GLUCOSE AND INSULIN PUMP HAD CRACK ON BATTERY COMPARTMENT. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 40 MG/DL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER TREATED WITH FOOD AND GLUCOSE TABLETS. CUSTOMER WAS NEITHER IN EMERGENCY ROOM NOR ADMITTED INTO HOSPITAL. BASED ON CUSTOMER REPORT CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS OVER DELIVERING AND REASON WAS THEY FEEL LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL BE AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10131574 ↗
• MalfunctionJun 2, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS OVER DELIVERING. CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 100 MG/DL. CUSTOMER WAS TREATED WITH FOOD. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ALLEGING INSULIN PUMP FOR OVER DELIVERING BECAUSE CUSTOMER HAD LOW BLOOD GLUCOSE LEVEL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10107538 ↗
• MalfunctionJun 1, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS OVER DELIVERING. THE CUSTOMER STATED THEY DID NOT TREAT THE ENSUING LOW, BUT ALLOWED THE INSULIN PUMP IN AUTO MODE TO ADJUST THEIR BASAL RATES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10105563 ↗
• MalfunctionJun 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR WAS LEAKING FROM TWO GUM RINGS. 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 10104668 ↗
• MalfunctionJun 1, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 22 MMOL/L AT THE TIME OF THE INCIDENT. THE CUSTOMER USED THE INSULIN PUMP AND MANUAL INJECTIONS TO TREAT THE HIGH. THE CUSTOMER WAS USING AUTO MODE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10104488 ↗
• MalfunctionMay 27, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT AIR BUBBLE IN RESERVOIR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STORED INSULIN BY ROOM TEMPERATURE. SIZED OF AIR BUBBLE 1 CENTIMETRE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10091023 ↗
• InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 25.9 MMOL/L. CUSTOMER REPORTED THAT THE PUMP WAS SUSPENDED BUT WOULD NOT RESUME. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. IT WAS UNKNOWN HOW THE CUSTOMER TREATED FOR THEIR HIGH BLOOD GLUCOSE WITH GLUCOSE. IT IS UNKNOWN IF TROUBLESHOOTING WAS COMPLETED FOR THE HIGH BLOOD GLUCOSE INCIDENT. THE CUSTOMER¿S BLOOD GLUCOSE AT THE TIME OF THE CALL WAS 11.5 MMOL/L. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10069363 ↗
• MalfunctionMay 15, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION INDICATED BY MEDTRONIC THAT THE RESERVOIR HAS HAD ISSUES WITH AIR BUBBLES. RESERVOIRS HAVE ALREADY BEEN REPLACED BUT THAT HAS NOT ENTIRELY RESOLVED THE ISSUE. NO FURTHER DETAILS PROVIDED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10060868 ↗
• MalfunctionMay 11, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEY ALLEGE INSULIN PUMP WAS OVER DELIVERING. CUSTOMER STATED THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL AND WAS RECOMMENDED TO TREAT WITH FOOD. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICE DISPATCHED AS A RESULT OF LOW BLOOD GLUCOSE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10042138 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001828. 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