MiniMed™ Reservoir MMT-332A (UDI 20763000273358)Recalls & reported problems

Summary

The FDA's MAUDE database contains 214 adverse event reports that list this exact device (DI 20763000273358), received between Jan 27, 2020 and Sep 4, 2020 — classified as 101 injuries, 113 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (59 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 214 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. BLOOD GLUCOSE READING WAS 39 MG/DL. CUSTOMER CURRENT BLOOD GLUCOSE LEVEL WAS 117 MG/DL. THE CUSTOMER TREATED FOR THEIR LOW WITH GLUCOSE TABLETS. THE CUSTOMER STATED THAT HE WAS NOT USING AUTO MODE FEATURE ACTIVE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10495935 ↗
• MalfunctionAug 18, 2020Improper Flow or Infusion; Improper Flow or Infusion

  CUSTOMER REPORTED VIA PHONE CALL AIR BUBBLES INSIDE OF THE RESERVOIR. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ADVISED THEIR WERE AIR BUBBLES INSIDE OF THE RESERVOIR EVEN THOUGH THEY ALLOWED THE INSULIN TO TURN INTO ROOM TEMPERATURE. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10418840 ↗
• InjuryAug 14, 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 EXPERIENCED HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READING WAS 400 MG/DL. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR THE HIGH BLOOD GLUCOSE INCIDENT. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER HAD SYMPTOMS LIKE HEADACHE. CUSTOMER WAS ALLEGING INSULIN PUMP FOR UNDER DELIVERING BECAUSE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL. CUSTOMER TREATED HIGH BLOOD GLUCOSE LEVEL WITH MANUAL INJECTION. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10406137 ↗
• MalfunctionAug 13, 2020Fluid/Blood Leak; Improper Flow or Infusion; Fluid/Blood Leak; Improper Flow or Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR HAD AIR BUBBLES. THE CUSTOMER ALSO MENTIONED THEY NOTICED A LEAK AND INSULIN SMELL FROM THE RESERVOIR. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 119 MG/DL NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10400326 ↗
• MalfunctionAug 12, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE CUSTOMER STATED THAT THE INSULIN PUMP DID NOT ALARM NO DELIVERY AND CHANGING THE RESERVOIR RESOLVED THE ISSUE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395330 ↗
• MalfunctionAug 12, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR HAD AIR BUBBLES. THE CUSTOMER NOTICED THE AIR BUBBLES DURING THERAPY. CUSTOMER DID NOT ALLOW FOR INSULIN TO WARM TO ROOM TEMPERATURE PRIOR TO FILLING RESERVOIR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10395309 ↗
• InjuryAug 12, 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 300 TO 400 MG/DL AND 218 MG/DL. CUSTOMER STATED THEY WAS HOSPITALIZED FOR NON-DIABETES REASON. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED WITH MANUAL INJECTION AND INSULIN PEN. 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. CUSTOMER STATED AUTO MODE FEATURE WAS NOT ACTIVE AT THE TIME OF INCIDENT. CUSTOMER STATED INSULIN PUMP HAD INSULIN FLOW BLOCK ALARM AND CRACK TO RETAINER RING. CUSTOMER STATED RESERVOIR WAS ABLE TO LOCK IN PLACE. THE INSULIN PUMP WILL NOT AND RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Complaint, Ill-Defined; Hyperglycemia

  MAUDE report 10394600 ↗
• MalfunctionAug 11, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP 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 10390411 ↗
• InjuryAug 11, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE LEVEL WAS 105 MG/DL. CUSTOMER REPORTED POSSIBLE UNDER DELIVERY OF INSULIN PUMP. CUSTOMER WAS NOT USED AUTO MODE DURING THE HIGH BLOOD GLUCOSE EVENT. CUSTOMER FOLLOWED TROUBLESHOOTING TILL HIGH PRESSURE TEST. THE INSULIN PUMP WILL BE RETURNED AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10389326 ↗
• InjuryAug 10, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVEL AND DIABETIC KETOACIDOSIS ON (B)(6) 2020. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 1236 MG/DL. CUSTOMER HAD BLOOD GLUCOSE LEVELS OF 260 AND 286 MG/DL. CUSTOMER WAS TREATED WITH INSULIN DRIP. CUSTOMER WAS NOT USING AUTO MODE. CUSTOMER STATED THAT THERE WAS NO AIR BUBBLES AND LEAK. CUSTOMER WAS ALLEGING INSULIN PUMP FOR UNDER DELIVERING BECAUSE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 10383816 ↗
• MalfunctionAug 7, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS OVER DELIVERING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10378061 ↗
• InjuryAug 6, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 564 MG/DL. THE CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER REPORTED THAT THEY TREATED HIGH BLOOD GLUCOSE LEVEL WITH INSULIN PUMP. THE CUSTOMER REPORTED THAT THEY EXPERIENCED FATIGUE. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICES DISPATCHED AS A RESULT OF HIGH BLOOD GLUCOSE. THE CUSTOMER ALLEGED THE INSULIN PUMP FOR UNDER DELIVERY BECAUSE THEY ALREADY SWITCHED SITES BUT SHE WAS STILL HAVING THE SAME ISSUE. THE INSULIN PUMP WAS NOT ON AUTO MODE AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10372317 ↗
• MalfunctionAug 6, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR DURING REWIND. CUSTOMER REPORTED THAT INSULIN PUMP WAS EXPOSED TO MOISTURE, RESERVOIR HAD LEAK AT PAST SECOND O RING. THERE WAS FLUID IN RESERVOIR COMPARTMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10372164 ↗
• InjuryAug 6, 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 31 MG/DL. THE CUSTOMER WAS TREATED WITH FOOD AND GLUCAGON. CUSTOMER WAS UNCONSCIOUS. CUSTOMER WAS IN EMERGENCY ROOM. THE CUSTOMER ALSO STATED THAT THEY DID ALLEGE INSULIN PUMP WAS OVER DELIVERING. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT AUTO MODE FEATURE WAS ACTIVE. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 10371567 ↗
• MalfunctionAug 5, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER ALLEGING POSSIBLE UNDER DELIVERY. CUSTOMER STATED THEY CHANGED THE INFUSION SET AND HALF HOUR PERFORMED A BOLUS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Sweating

  MAUDE report 10371469 ↗
• InjuryAug 5, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THEY HAD A HIGH BLOOD GLUCOSE VALUE OF 500 MG/DL AND CUSTOMER ALLEGING POSSIBLE INSULIN PUMP UNDER DELIVERY. THE CUSTOMER WAS TREATED WITH BOLUS. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE. THE CUSTOMER WAS NOT USING AUTO MODE FEATURE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10366064 ↗
• InjuryAug 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 510 MG/DL. CUSTOMER STATED RESERVOIR HAD LEAK. CUSTOMER WAS PERFORMED SELF TEST AND DISPLACEMENT TEAT AND INSULIN PUMP HAD HARDWARE LOW LEVEL FAILURE ALARM. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND THEY WERE ABLE TO REWIND INSULIN PUMP. IT WAS UNKNOWN THAT CUSTOMER WAS USING AUTO MODE OR NOT. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10355805 ↗
• InjuryAug 3, 2020Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER TREATED WITH THE MANUAL INJECTION. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN PROPERLY. THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER ALLEGED THAT THE INSULIN PUMP WAS UNDER DELIVERING INSULIN DUE TO ELEVATED BLOOD GLUCOSE. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10355308 ↗
• MalfunctionAug 3, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION INDICATED BY MEDTRONIC THAT THE CUSTOMER RECEIVED A NO DELIVERY ALARM. TROUBLESHOOTING WAS COMPLETED FOR THE NO DELIVERY ALARM. DURING TROUBLESHOOTING FOR THE NO DELIVERY ALARM, THE INFUSION SET WAS CHANGED FIRST BUT NO INSULIN EXITED WHEN PRIMING. THE RESERVOIR WAS THEN CHANGED AND INSULIN EXITED WHILE PRIMING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10354646 ↗
• InjuryAug 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT CUSTOMER WAS EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND RESERVOIR WAS LEAKING. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 24.4 MMOL/L AT THE TIME OF THE INCIDENT. IT WAS REPORTED THAT THE CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL WAS 22.9 MMOL/L. CUSTOMER STATED THAT THE INSULIN PUMP HAD INSULIN FLOW BLOCK ALARM. TROUBLESHOOTING WAS PERFORMED. CUSTOMER REPORTED THAT EVENT WAS RESOLVED BY CHANGING COMPLETE SET. THE DEVICE WILL BE RETURNED FOR ANALYSIS. UNOMED SET.

  Patient problems: Hyperglycemia

  MAUDE report 10354337 ↗
• MalfunctionJul 31, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER HAD EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND HAD ALLEGED THAT THE INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 246 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS TREATED WITH CORRECTION BOLUS. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10348997 ↗
• InjuryJul 30, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER'S FATHER WAS REPORTED VIA PHONE CALL THAT, THE CUSTOMER HAD LOW BLOOD GLUCOSE AND ALSO OVER DELIVERING THE INSULIN. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 32 MG/DL. THE CUSTOMER FIRST STARTED GETTING LOW BLOOD GLUCOSE AND ON THURSDAY HE HAD 3 SEIZURES, HIS GOTTEN WAY LOWER TO 24 MG/DL THIS MORNING HAD TO TAKE GLUCAGON AND BROUGHT HIM TO 50 MG/DL. THE CUSTOMER MADE CHANGES BECAUSE HE THINKS SOMETHING WAS WRONG WITH HIS PUMP AND CURRENT BLOOD GLUCOSE VALUE AS 171 MG/DL. THE CUSTOMER TREATED LOW BLOOD GLUCOSE WITH FOOD AND GLUCOSE TABLETS. THE SYMPTOMS RELATED TO LOW BLOOD GLUCOSE WERE SWEATING, OTHER SEIZURES AND LOSS OF CONSCIOUSNESS AND ALL HAPPENED WHEN HE WAS IN BED. FOR QUICK RECOVERY THE CUSTOMER'S MOTHER DID TREATMENTS USING HONEY, SYRUP AND GLUCOSE GEL WHEN HE'S BLOOD GLUCOSE WAS 24 MG/DL SHE USED GLUCAGON. THE CUSTOMER WAS USING AUTO MODE FUNCTION AT THE TIME OF THE EVENT. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia; Seizures

  MAUDE report 10343248 ↗
• MalfunctionJul 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT LEAK ON RESERVOIR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10342675 ↗
• MalfunctionJul 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR WAS LEAKING. CUSTOMER STATED THAT THE RETAINER RING WAS CRACKED. CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10342363 ↗
• InjuryJul 29, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 3 MMOL/L. CUSTOMER ATE FOOD BUT THEY STILL HAD LOW BLOOD GLUCOSE LEVEL. CUSTOMER DID THE AUTO TEST AND THEY RECEIVED HARDWARE LOW LEVEL FAILURE ALARM. CUSTOMER ALLEGED THE OVER DELIVERY. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10337142 ↗

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