MiniMed™ Reservoir MMT-332A (UDI 70643169771481)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,013 adverse event reports that list this exact device (DI 70643169771481), received between May 11, 2017 and Dec 21, 2020 — classified as 2 deaths, 1,322 injuries, 1,689 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (613 reports).

1 other recall cover devices cleared under the same FDA submission (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 3,013 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER¿S HUSBAND REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED THE LOW BLOOD GLUCOSE OF 40 MG/DL AND DOCTOR HAD TAKEN HER PUMP AWAY FROM HER. THE CUSTOMER WAS OVERDOSED AND THEY WERE IN THE NURSING HOME. THE CUSTOMER¿S HUSBAND DECLINED THE LOW BLOOD GLUCOSE TROUBLESHOOT. THE DEVICES WILL NOT BE RETURNED FOR THE ANALYSIS. UPDATED SUMMARY: THE CUSTOMER WAS NOT USING AUTO MODE AT THE TIME OF THE INCIDENT PER THE CUSTOMER'S DOCTOR'S OFFICE. THE CUSTOMER HAD LOW SYMPTOMS SUCH AS BEING UNRESPONSIVE. THE CUSTOMER'S BLOOD GLUCOSE WAS 70 MG/DL AT THE TIME OF HOSPITALIZATION. THE CUSTOMER WAS GIVEN GLUCAGON TO TREAT THE LOW. THE CALLER STATED THE CUSTOMER HAD BEEN GETTING FORGETFUL RECENTLY. THE PUMP WAS DONATED TO THE DOCTOR'S OFFICE. 2ND UPDATED SUMMARY: THE CUSTOMER'S SPOUSE CALLED AND STATED THAT THE CUSTOMER WAS NO LONGER ON THE PUMP. THE CALLER STATED THE CUSTOMER WAS USING THE PUMP IN MANUAL MODE AND IT OVER DELIVERED. THE CUSTOMER HAS BEEN IN A NURSING HOME SINCE THE INCIDENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 11045383 ↗
• InjuryAug 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WAS EXPERIENCED HIGH BLOOD GLUCOSE DUE TO LEAK. BLOOD GLUCOSE VALUE AT THE TIME OF INCIDENCE WAS 500 MG/DL. CUSTOMER REPORTED THAT RESERVOIR WAS LEAKING. INSULIN WAS VISIBLE IN RESERVOIR COMPARTMENT. CUSTOMER REPORTED ALL COMPONENTS WERE NOT PRESENT. CUSTOMER STATED THAT LOCATION OF LEAKAGE WAS UNKNOWN. THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10406721 ↗
• MalfunctionAug 10, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD REPETITIVE NO DELIVERY ALARM. THEY REPORTED THAT THEY ALREADY CHANGED THE RESERVOIR FROM OTHER BOX AND THE ALARM WAS RESOLVED. 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 10384106 ↗
• MalfunctionAug 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR WAS LEAKING IN THE RESERVOIR COMPARTMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10383644 ↗
• MalfunctionAug 6, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR LEAKED INSULIN. NO FURTHER DETAILS GIVEN. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. 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 10372616 ↗
• MalfunctionAug 6, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER ALLEGED POSSIBLE UNDER DELIVERY. CUSTOMER WAS PERFORMED SELF TEST AND IT WAS PASS AND HIGH PRESSURE TEST WAS FAIL. THE CUSTOMER WAS TREATED WITH BOLUS FOR HIGH BLOOD GLUCOSE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Blood Loss; Hyperglycemia

  MAUDE report 10372357 ↗
• MalfunctionAug 6, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEW RESERVOIR LEAKING AT BOTH RESERVOIR O-RING. 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 10371887 ↗
• MalfunctionAug 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR WAS LEAK INSULIN. 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 10367515 ↗
• MalfunctionAug 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT NEW RESERVOIR LEAK INSULIN. 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 10367490 ↗
• MalfunctionAug 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD LEAK AT TRANSFER GUARD. THE CUSTOMER STATED INSULIN PUMP HAD LEFT BUTTON WAS NOT RESPONDING BEFORE BUT EVENTUALLY IT WORKED AGAIN BUT NOW SHE GOT PUMP ERROR ALARM. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM AND WAS ABLE TO COMPLETE REWIND AND SELF TEST PASSED. 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 10366205 ↗
• InjuryAug 4, 2020Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; No Apparent Adverse Event

  IT WAS REPORTED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE AND THEY DID ALLEGE INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 33.3 MMOL/L. CUSTOMER STATED THAT INSULIN PUMP HAD NO DELIVERY ALARM. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS NEITHER IN EMERGENCY ROOM NOR ADMITTED INTO HOSPITAL. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10360494 ↗
• MalfunctionAug 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE WAS LEAK AT THE TOP OF RESERVOIR. NO FURTHER DETAILS GIVEN. 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 10355303 ↗
• MalfunctionJul 29, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT RESERVOIR HAD AIR BUBBLES. CUSTOMER STATED AIR BUBBLES OCCURRED AFTER 1 HOUR. CUSTOMER STATED SIZE OF AIR BUBBLES WAS 2 CENTIMETRE. 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 10337228 ↗
• MalfunctionJul 29, 2020Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Flow or Under Infusion; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNDER DELIVERY. THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND IT WAS TREATED WITH INSULIN PUMP. THE CUSTOMER WAS USING THE INSULIN PUMP WHEN HIGH BLOOD GLUCOSE EVENT WAS REPORTED. THE CUSTOMER WAS REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. INSULIN PUMP HAD NO DELIVERY ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Pain

  MAUDE report 10336978 ↗
• MalfunctionJul 28, 2020Fluid/Blood Leak; Patient Device Interaction Problem; Fluid/Blood Leak; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRITICAL PUMP ERROR ALARM. CUSTOMER STATED THAT THE RESERVOIR WAS LEAKING FROM THE 2ND O RING. 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 10331160 ↗
• MalfunctionJul 27, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RESERVOIR HAD LEAK AT THE O RINGS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10325301 ↗
• MalfunctionJul 24, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER ALLEGED THE INSULIN PUMP FOR OVER DELIVERY DUE TO LOW BLOOD GLUCOSE LEVEL. THE CUSTOMER HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVEL AND TREATED WITH FOOD. THE INSULIN PUMP WAS NOT ON AUTO MODE AT THE TIME OF INCIDENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10318323 ↗
• InjuryJul 23, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WERE EXPERIENCING HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 424 MG/DL AND 151 MG/DL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED WITH MANUAL INJECTION AND INSULIN PUMP. CUSTOMER STATED THEY DID NOT CONTACT THEIR HEALTH CARE PROFESSIONAL REGARDING HIGH BLOOD GLUCOSE. CUSTOMER WAS NEITHER IN EMERGENCY ROOM NOR ADMITTED INTO HOSPITAL. BASED ON CUSTOMER REPORT CUSTOMER DID ALLEGE INSULIN PUMP WAS UNDER DELIVERING AND REASON WAS MOTOR NOT WORKING PROPERLY. CUSTOMER PERFORMED SELF TEST AND HARDWARE LOW LEVEL FAILURE ALERT OCCURRED. CUSTOMER STATED AUTO MODE FEATURE WAS NOT ACTIVE AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL BE AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10313320 ↗
• InjuryJul 22, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 40 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THEY DID ALLEGE INSULIN PUMP WAS OVER DELIVERING. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER REPORTED THAT IT WAS UNKNOWN THAT AUTO MODE FEATURE WAS ACTIVE OR NOT AT THE TIME OF EVENT. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICE DISPATCHED AS A RESULT OF LOW BLOOD GLUCOSE. CUSTOMER EXPERIENCED THE UNEXPECTED LOW BLOOD GLUCOSE AFTER SHE WENT SWIMMING WITH THE INSULIN PUMP. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL BE AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10306953 ↗
• MalfunctionJul 20, 2020Fluid/Blood Leak; Patient Device Interaction Problem; Fluid/Blood Leak; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD LEAKAGE. CUSTOMER REPORTED RESERVOIR WAS DISCARDED AND LEAKAGE OCCURRED AT SNAP CAP. 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 10300040 ↗
• MalfunctionJul 20, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER ALLEGED THE INSULIN PUMP FOR OVER DELIVERY. THE CUSTOMER ALSO REPORTED THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL AND TREATED WITH FOOD. THE DRIVE SUPPORT CAP APPEARED NORMAL. THE CUSTOMER ALLEGED THE INSULIN PUMP FOR OVER DELIVERY BECAUSE THE CUSTOMER MENTIONED THAT NORMALLY HER BLOOD GLUCOSE LEVELS WERE OKAY BUT ONCE SHE RESUMED INSULIN PUMP THERAPY AFTER BEING OFF FOR SEVERAL MONTHS, SHE STARTED HAVING LOW BLOOD GLUCOSE LEVELS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP AND RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10294036 ↗
• MalfunctionJul 17, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR WAS LEAKING. 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 10287544 ↗
• MalfunctionJul 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S RESERVOIR WAS LEAKED. CUSTOMER STATED THAT IT WAS HAPPENING ONCE IN WEEK. CUSTOMER WAS IN SHORT OF NEW RESERVOIR. 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 10275180 ↗
• MalfunctionJul 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT RESERVOIR WAS LEAKING. CUSTOMER ALSO STATED THAT BLOOD GLUCOSE WAS NORMAL. 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 10275104 ↗
• InjuryJul 15, 2020Fluid/Blood Leak; Insufficient Flow or Under Infusion; Fluid/Blood Leak; 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 429 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. CUSTOMER STATED RESERVOIR WAS LEAK AT PAST FIRST O RING. CUSTOMER WAS NOT USING AUTO MODE. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS AND RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10274572 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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