MiniMed ReservoirRecalls & reported problems across all models

We found 6 models of MiniMed Reservoir by Medtronic Minimed, Inc. in the FDA's device registry (GUDID). Together they are named in 4,545 adverse event reports in the FDA's MAUDE database, received between May 11, 2017 and Dec 21, 2020 — classified as 3 deaths, 2,037 injuries, 2,505 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (817 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported MiniMed Reservoir problems

MiniMed Reservoir models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MiniMed™ Reservoir MMT-332A

  Automated insulin dosing device system, single hormonal control
  2 deaths3,013 reports
• MiniMed Reservoir MMT-326A

  Automated insulin dosing device system, single hormonal control
  1 death762 reports
• MiniMed Reservoir MMT-332A

  Pump, infusion
  342 reports
• MiniMed™ Reservoir MMT-332A

  Automated insulin dosing device system, single hormonal control
  214 reports
• MiniMed Reservoir MMT-326A

  Pump, infusion
  184 reports
• MiniMed™ Reservoir MMT-326A

  Automated insulin dosing device system, single hormonal control
  30 reports

Recent MiniMed Reservoir adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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