MiniMed Reservoir MMT-332ARecalls & reported problems

Summary

The FDA's MAUDE database contains 342 adverse event reports that list this exact device (DI 00643169786547), received between Jun 6, 2017 and Aug 4, 2020 — classified as 185 injuries, 157 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (52 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 342 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2020Excess Flow or Over-Infusion; Appropriate Device Problem Term/Code Not Available; Excess Flow or Over-Infusion; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC LEGAL RECEIVED INFORMATION REGARDING THE CUSTOMER¿S HOSPITALIZATION FROM THE ATTORNEY OF THE FAMILY. THE INFORMATION RECEIVED ON (B)(6) 2020 STATED THE FOLLOWING - REPORTER ALLEGES: IN OR ABOUT (B)(6) 2018 THE CUSTOMER BEGAN USING THE INSULIN PUMP. ON OR ABOUT THE (B)(6) 2018, THE CUSTOMER WAS FOUND UNCONSCIOUS BY EMERGENCY MEDICAL SERVICES AND TRANSPORTED TO A HOSPITAL WHERE THEY WERE FOUND TO BE SEVERELY HYPOGLYCEMIC AS A RESULT OF AN INSULIN OVERDOSE. THE CUSTOMER HAD SUFFERED HYPOGLYCEMIC ENCEPHALOPATHY AND WAS HOSPITALIZED OVERNIGHT. THE PUMP DID NOT ALARM TO ALERT THE CUSTOMER OF THE LOW. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 10365824 ↗
• MalfunctionJul 30, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT DID ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER REPORTED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER REPORTED THAT AUTO MODE FEATURE WAS NOT ACTIVE AT TIME OF HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICE DISPATCHED AS A RESULT OF HIGH BLOOD GLUCOSE. CUSTOMER TREATED WITH INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS. ¿

  Patient problems: Hyperglycemia

  MAUDE report 10343075 ↗
• MalfunctionJul 29, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD AIR BUBBLE PRIOR TO CHANGING. THE CUSTOMER STATED THAT INSULIN PUMP HAD AIR BUBBLES IT WAS STUCK TO THE SIDE WHERE INSULIN WAS NOT MOVING. THE CUSTOMER EXPERIENCING HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH BOLUS. THE CUSTOMER REPORTED THAT CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10336736 ↗
• InjuryJul 27, 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 THE CUSTOMER VISITED TO EMERGENCY ROOM DUE TO LOW BLOOD GLUCOSE LEVEL ON (B)(6) 2020. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 50 MG/DL, AT THE TIME OF INCIDENCE. CUSTOMER WAS TREATED WITH FOOD FOR LOW BLOOD GLUCOSE LEVEL. CUSTOMER WAS NOT USING AUTO MODE AT THE TIME OF INCIDENCE. CUSTOMER REPORTED INSULIN PUMP WAS OVER DELIVERING THE INSULIN WITHOUT USER INPUT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. FRN-MMT-332A-RSVR, UNOMED SET.

  Patient problems: Hypoglycemia

  MAUDE report 10330580 ↗
• MalfunctionJul 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT RESERVOIR HAD LEAK ON PAST SECOND O RING. CUSTOMER STATED SEAL AT THE BOTTOM OF RESERVOIR CAME OUT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10268976 ↗
• InjuryJul 10, 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 HAD A LOW BLOOD GLUCOSE VALUE OF 45 MG/DL. THE CUSTOMER WAS TREATED WITH CARBOHYDRATE. CUSTOMER WAS NOT USING AUTO MODE. CUSTOMER STATED THAT THE RETAINER RING WAS LOOSE. CUSTOMER ALLEGED INSULIN PUMP WAS OVER DELIVERING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10256167 ↗
• InjuryJun 23, 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 WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS FROM (B)(6) 2020 WITH BLOOD GLUCOSE OF 520 MG/DL. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA AND VOMITING. THE CUSTOMER WAS TREATED WITH INSULIN PUMP AND INTRAVENOUS DRIP. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER ALLEGING POSSIBLE INSULIN PUMP UNDER DELIVERY. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. THE CUSTOMER STATED THAT THEY WERE NOT USING THE AUTO MODE FEATURE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Nausea; Vomiting

  MAUDE report 10183254 ↗
• InjuryMay 8, 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 EXPERIENCING LOW BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 28 MG/DL. CUSTOMER STATED THAT WAS HAVING ISSUES WITH LOW BLOOD GLUCOSE AT NIGHT AND WAS FOUND ON THE FLOOR BY WIFE. CUSTOMER HAS TREATED WITH GLUCOSE TABLETS. CUSTOMER HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE FOR OVER 2 MONTHS. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. AUTO MODE OR SMART GUARD WAS AUTOMATICALLY DELIVERING INSULIN AT THE TIME OF LOW BLOOD GLUCOSE EVENT. CUSTOMER BELIEVED INSULIN PUMP WAS OVER DELIVERING. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 10038335 ↗
• MalfunctionApr 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD AN ERROR IN THE MOTOR DETECTED BY READING AN UNEXPECTED VALUE FROM HALL SENSOR AND RESERVOIR LEAK ANOMALY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. CUSTOMER ADVISED THE RESERVOIR LEAKED PAST THE SECOND O RING AND THE ISSUE REMAINED UNRESOLVED. CUSTOMER ADVISED THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9999097 ↗
• InjuryApr 21, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD EXPERIENCED HYPERGLYCEMIA WITH BLOOD GLUCOSE LEVEL OF 300 MG/DL TO 400 MG/DL. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER WAS TREATED WITH BOLUS FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICE DISPATCHED AS A RESULT OF HIGH BLOOD GLUCOSE LEVEL. CUSTOMER DID ALLEGE INSULIN PUMP WAS UNDER DELIVERING AS SHE SMELLED INSULIN. CUSTOMER STATED THAT INSULIN PUMP HAD PASSED THE HIGH PERFORMANCE TEST. THE INSULIN PUMP AND THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9980175 ↗
• MalfunctionApr 20, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED INSULIN FLOW BLOCK ALARM. CUSTOMER STATED THAT ALARM DID NOT OCCUR DURING FILL TUBING AND EVENT WAS RESOLVED BY RESERVOIR CHANGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9978206 ↗
• MalfunctionApr 9, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9946202 ↗
• MalfunctionMar 11, 2020Obstruction of Flow; Failure to Align; Manufacturing, Packaging or Shipping Problem; Obstruction of Flow; Failure to Align; Manufacturing, Packaging or Shipping Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN FLOW BLOCKED ALARM. THE TROUBLESHOOTING WAS PERFORMED FOR THE HIGH BLOOD GLUCOSE AND INSULIN FLOW BLOCKED ALARM. THE CUSTOMER REPORTED THAT EVENT WAS RESOLVED BY RESERVOIR CHANGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9816384 ↗
• InjuryMar 6, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS ADMITTED TO HOSPITAL DUE TO DIABETIC KETOACIDOSIS, HYPERGLYCEMIA, ON (B)(6) 2020 WITH 251 MG/DL BLOOD GLUCOSE LEVEL. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS, ELECTROLYTES, MUSCLE RELAXANTS, PAIN KILLERS AND INSULIN IN HOSPITAL. CUSTOMER REPORTED THAT THEY FEEL OKAY TO TROUBLESHOOTING. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER REPORTED THAT THEY HAD CONTACTED THEIR HEALTH CARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE. CUSTOMER ALLEGES INSULIN PUMP WAS UNDER DELIVERING BECAUSE THEIR BLOOD GLUCOSE LEVEL DID NOT GOING DOWN EVEN AFTER DELIVERING CORRECTION BOLUS. THE CUSTOMER WAS USED AUTO MODE FEATURE. THE RESERVOIR WILL NOT BE AND INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9802676 ↗
• MalfunctionMar 3, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN FLOW BLOCKED ALARM. CUSTOMER STATED THEY HAD CHANGED RESERVOIR AND ISSUE WAS RESOLVED. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9778493 ↗
• MalfunctionFeb 27, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER CALLED AND REPORTED THAT THEIR INSULIN PUMP WAS OVER DELIVERING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 63 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER TREATED THE LOWS WITH FOOD. THE AUTO MODE ON THE INSULIN PUMP WAS NOT ACTIVE AND AUTOMATICALLY ADJUSTING INSULIN DELIVERY DURING THE EVENT. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9761929 ↗
• InjuryFeb 25, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED VIA PHONE CALL BY THE CUSTOMER'S PARENT THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE ON (B)(6) 2020 WITH BLOOD GLUCOSE OF 44 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER USED FOOD TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE AUTO MODE ON THE INSULIN PUMP WAS ACTIVE AND AUTOMATICALLY ADJUSTING INSULIN DELIVERY DURING THE EVENT. THE CUSTOMER ALLEGED PUMP OVER DELIVERY. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9749080 ↗
• MalfunctionNov 29, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 200 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS TIRED, THIRSTY, AND A LITTLE NAUSEOUS. THE CUSTOMER REPORTED THAT THEY FEEL OKAY FOR TROUBLESHOOTING. THE CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP WAS IN AUTO MODE AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THEY DO NOT HAVE A BACK-UP PLAN AVAILABLE. THE AUTO MODE FEATURE WAS NOT ACTIVE AND WAS NOT AUTOMATICALLY ADJUSTING INSULIN AT TIME OF HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER WAS UNABLE TO BRING SUGAR DOWN, BUT HAD TO TAKE BOLUS EVERY 2 HOURS. THE CUSTOMER WAS CALLING BACK TO PERFORM A HIGH PRESSURE TEST. THE CUSTOMER REPORTED THAT THE SITE WAS CHANGED EVERY 2/3 DAYS. THE CUSTOMER WAS USING A CANNULA BASED INFUSION SET. THE CUSTOMER DECLINED TO TEST THE INSULIN PUMP. THE CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND INSULIN AND TREAT PER THE HEALTHCARE PROFESSIONAL¿S INSTRUCTIONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9391214 ↗
• InjuryNov 4, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE AND NO DELIVERY ALARM. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 600 MG/DL. TROUBLESHOOTING WAS UNABLE TO BE PERFORMED SINCE CUSTOMER REMOVED THE RESERVOIR ALREADY, BUT THE CUSTOMER INSISTED THAT IT WAS A RESERVOIR PROBLEM. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9276403 ↗
• InjuryOct 18, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  CUSTOMER CALLED AND REPORTED THAT THEY EXPERIENCED LOW BLOOD GLUCOSE ON OCTOBER 9, 2019 WITH BLOOD GLUCOSE OF 39 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 103 MG/DL A FEW MINUTES AFTER THE LOW. THE CUSTOMER DID NOT MENTION HOW THEY TREATED. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER ALLEGED THE PUMP WAS OVER DELIVERING. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE CUSTOMER HAD ISSUES WITH THE PUMP NOT ACCEPTING A BATTERY ON TWO OCCASIONS AND THEY HAD TO GO TO A DOCTOR. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9206217 ↗
• MalfunctionSep 20, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WAS TRYING TO REFILL RESERVOIR BUT IT DID NOT WORK, THEY PUT IN THE NEW CYLINDER AND ALSO CHANGE THE BATTERY. WHEN THEY TRIES TO FILL TUBING GETS A NO DELIVERY ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 200 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THEY PERFORMED 5 UNIT FIXED PRIME. CUSTOMER STATES THE INSULIN DID NOT EXIT AND INSULIN PUMP ALARMED NO DELIVERY. CUSTOMER STATED THAT THEY RUN MANUAL PRIME WITH EMPTY INSULIN PUMP UNTIL PISTON REACHES END OF TRAVEL AND INSULIN PUMP ALARMED WITH NO RESERVOIR. CUSTOMER STATED THAT THE PLUNGER WAS AVAILABLE, THEY PUSH INSULIN SLOWLY THROUGH THE TUBING. CUSTOMER STATED THAT THE INSULIN DID NOT EXIT WITH PLUNGER PUSH. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9097160 ↗
• InjurySep 18, 2019Insufficient 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 WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2019. CUSTOMER¿S BLOOD GLUCOSE WAS 400 MG/DL AT THE TIME OF HOSPITALIZATION. CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER HAD SYMPTOMS SUCH AS ABDOMINAL PAIN AND DIFFICULTY BREATHING. CUSTOMER WAS ALLEGING INSULIN PUMP FOR UNDER DELIVERING BECAUSE CUSTOMER IS UNABLE TO HEAR THE PUMP WHEN IT WAS DELIVERING BASAL. CUSTOMER STATED THAT THERE WAS NO AIR BUBBLE AND LEAK. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER REPORTS INSULIN EXITED AT THE QUICK RELEASE. CUSTOMER STATED THAT THE INSULIN PUMP PASSED DISPLACEMENT TEST. CUSTOMER DECLINED TO PERFORM HIGH PRESSURE TEST. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS AND THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS..

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 9080651 ↗
• MalfunctionSep 11, 2019Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR WAS LEAK AT O RING'S AND INSULIN PUMP RECEIVED INSULIN FLOW BLOCKED ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT INSULIN PUMP WAS EXPOSED TO MOISTURE AND INSULIN WAS LEAKED TO THE RESERVOIR COMPARTMENT. IT WAS ALSO REPORTED THAT CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE AND INSULIN FLOW BLOCKED ALARM. THE CUSTOMER STATED THAT THEY DID NOT RECEIVED ANY ALARMS IMMEDIATELY AFTER MOISTURE EXPOSURE AND INSULIN PUMP DID NOT PASSED SELF TEST. THE RESERVOIR WILL BE RETURNED AND INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8986899 ↗
• MalfunctionSep 3, 2019Fluid/Blood Leak; Moisture Damage

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN SQUIRTED OUT AND RESERVOIR HAD LEAK AT PAST THE O RINGS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 168 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT THE SELF TEST WAS PASSED. CUSTOMER STATED THAT LEAK OCCURRED DURING PRIMING. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE. THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8958435 ↗
• InjuryAug 29, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WENT TO EMERGENCY ROOM DUE TO DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF ALMOST 600 MG/DL ON (B)(6) 2019. CUSTOMER'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS OVER 700 MG/DL. CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER ALLEGED POSSIBLE UNDER DELIVERY ON INSULIN PUMP. CUSTOMER HAD NAUSEA, VOMITING AND POSITIVE KETONE TEST. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL AND EXITED AT QUICK RELEASE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 8943506 ↗

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