MiniMed Reservoir MMT-326A (UDI 00643169771413)Recalls & reported problems

Summary

The FDA's MAUDE database contains 184 adverse event reports that list this exact device (DI 00643169771413), received between May 16, 2017 and Jun 25, 2020 — classified as 108 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (44 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 184 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 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. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE CUSTOMER DID NOT EXPERIENCE ANY SYMPTOMS OF HIGH BLOOD GLUCOSE VALUE. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. BASED ON CUSTOMER¿S REPORT CUSTOMER DID ALLEGE UNDER DELIVERY. THE CUSTOMER WAS USING THE INSULIN PUMP WHEN HIGH BLOOD GLUCOSE EVENT WAS REPORTED. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. THE CUSTOMER WAS REPORTED THAT THE INSULIN PUMP WAS ON AUTO MODE. HIGH PRESSURE TEST DID NOT PASS. THE INSULIN PUMP WILL BE RETURNED AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10193564 ↗
• MalfunctionMay 13, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE OF 70 MG/DL. THE CUSTOMER ALLEGED THE INSULIN PUMP WAS OVER DELIVERING INSULIN DUE TO SHE STARTED THE LOW EVENTS WHEN SHE STARTED USING THE REPLACEMENT INSULIN PUMP IN JANUARY. CUSTOMER WAS TREATED WITH FOOD. CUSTOMER WAS ABLE TO COMPLETE CARELINK UPLOAD. CUSTOMER WAS USING AUTO MODE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10050921 ↗
• InjuryApr 16, 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 LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 428 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS TREATED WITH MANUAL INJECTIONS. CUSTOMER HAD ALLEGED THAT THE INSULIN PUMP WAS UNDER DELIVERING BECAUSE EVEN AFTER CHANGING THE INFUSION SET THE BLOOD GLUCOSE LEVEL DID NOT CAME DOWN. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER ALSO REPORTED THAT THE RESERVOIR LIP RING WAS BROKEN OFF AND THE BATTERY CONTACT BROKE OFF THE BATTERY CAP. THE DEVICE AND THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9966976 ↗
• InjuryNov 10, 2019Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE AND ALLEGING POSSIBLE INSULIN PUMP UNDER DELIVERY. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA. THE CUSTOMER WAS TREATED WITH INSULIN PUMP AND MANUAL INJECTION. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER REPORTED THAT INSULIN EXITED AT THE QUICK RELEASE. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Nausea

  MAUDE report 9302892 ↗
• MalfunctionOct 9, 2019Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD LOT OF AIR BUBBLES IN THE RESERVOIR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE AIR BUBBLES ARE IN WHOLE RESERVOIR. CUSTOMER STATED THAT THE AIR BUBBLES WERE NOT REMOVED SUCCESSFULLY. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9170159 ↗
• MalfunctionOct 5, 2019Improper Flow or Infusion; Adverse Event Without Identified Device or Use Problem; Improper Flow or Infusion; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THERE WERE AIR BUBBLES INSIDE THE RESERVOIR. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER STATED THAT THEY OBSERVED AIR BUBBLES DURING THE THERAPY. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE AIR BUBBLES WERE NOT REMOVED SUCCESSFULLY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Discomfort

  MAUDE report 9159672 ↗
• MalfunctionOct 4, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD NO DELIVERY ALARM DURING MANUAL PRIME. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY HAD ISSUES DURING REWIND AND INSULIN PUMP DID NOT ALARM NO DELIVERY WITH MANUAL PRIME. THE TROUBLESHOOTING WAS PERFORMED AND WAS ADVISED TO ASSEMBLE A NEW INFUSION SET WITH CURRENT RESERVOIR. IT WAS REPORTED THAT THEY HAD CHANGED RESERVOIR AND RESOLVED THE ISSUE. THE CUSTOMER WAS ADVISED TO RETURN THE RESERVOIR. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9155048 ↗
• InjurySep 2, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 500 MG/DL. THE CUSTOMER TREATED WITH THE MANUAL INJECTION. THE DRIVE SUPPORT CAP APPEARED NORMAL. THE CUSTOMER WAS ALLEGING INSULIN PUMP WAS UNDER DELIVERING BECAUSE MANUAL INJECTIONS BRING HER GLUCOSE DOWN. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8953209 ↗
• MalfunctionAug 28, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  CUSTOMER CALLED AND REPORTED THAT THEY EXPERIENCED LOW BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 75 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER USED GLUCOSE TABLETS AND FOOD TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER BELIEVES THE PUMP WAS OVER DELIVERING. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8940259 ↗
• InjuryJul 10, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPOGLYCEMIA. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 40 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH GLUCOSE AND FOOD. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER DID NOT MENTION ANY TREATMENTS RELATED TO LOW BLOOD GLUCOSE EVENT. CUSTOMER WAS ALLEGING INSULIN PUMP WAS OVER DELIVERING. CUSTOMER STATED THAT THEY WERE NOT ADMITTED TO EMERGENCY ROOM, NOR HOSPITAL OR NOR TO EMERGENCY MEDICAL SERVICE. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8774792 ↗
• InjuryJul 8, 2019Excess Flow or Over-Infusion; No Apparent Adverse Event; Excess Flow or Over-Infusion; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL AND ALSO ALLEGE INSULIN PUMP WAS OVER DELIVERING. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 25 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER WAS USES AUTO MODE. CUSTOMER REPORTED AUTO MODE WAS AUTOMATICALLY DELIVERING INSULIN AT THE TIME OF LOW BLOOD GLUCOSE EVENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH FOOD. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8766622 ↗
• InjuryJun 27, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE AND GOT HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 38 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 45 MG/DL AT THE TIME OF ADMISSION. THE CUSTOMER STATED THAT THE KINKED TUBING WAS BUILDING UP INSULIN AND CAUSED THE LOW. THE CUSTOMER USED FOOD, GLUCOSE TABLETS, AND WAS GIVEN INTRAVENOUS GLUCOSE TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER REPORTED KINKED TUBING. THE CUSTOMER BELIEVES THE PUMP WAS OVER DELIVERING. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8738520 ↗
• InjuryJun 5, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT THE DAUGHTER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 41 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WAS TREATED WITH GLUCOSE AND CARBS FOR LOW BLOOD GLUCOSE LEVEL. CUSTOMER HAD USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER REPORTS THEY DID NOT CONTACT THEIR HEALTH CARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE. CUSTOMER DID ALLEGE INSULIN PUMP WAS OVER DELIVERING BECAUSE BOLUS HISTORY SHOWING 3.40U DELIVERED WHICH THEY DID NOT. CUSTOMER STATED DRIVE SUPPORT CAP APPEARED TO BE NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8669371 ↗
• InjuryJun 3, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 11 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THE OTHER BLOOD GLUCOSE VALUE WAS 342 MG/DL, 300 MG/DL TO 500 MG/DL. CUSTOMER STATED INSULIN PUMP WAS ALLEGING OVER DELIVERY. CUSTOMER STATED THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER WAS TREATED WITH FOOD. CUSTOMER HAD USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8661696 ↗
• MalfunctionMay 9, 2019Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR HAD AIR BUBBLES AND ALSO HAD TOO MUCH PRESSURE. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8594868 ↗
• MalfunctionMar 1, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED VIA PHONE CALL THAT AIR BUBBLES WERE PRESENT IN RESERVOIR. BLOOD GLUCOSE WAS 350 MG/DL. CUSTOMER ALSO REPORTED THAT THERE WAS LEAK IN RESERVOIR ALSO. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THE LEAK WAS FOUND IN 1ST O RING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS AND ONE RESERVOIR WAS RETURNED AND ANOTHER WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8380962 ↗
• MalfunctionFeb 21, 2019Fluid/Blood Leak; Patient Device Interaction Problem; Fluid/Blood Leak; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD RESERVOIR LEAK. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED THAT THE PLUNGER WAS NOT COMING OUT. THE CUSTOMER REPORTED THAT MISSING BLACK O RINGS. AFTER TROUBLESHOOTING, CUSTOMER WAS ADVISED THE RESERVOIR WILL BE REPLACED. THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8360647 ↗
• InjuryFeb 20, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVELS IN THE 40 MG/DL AND 50 MG/DL RANGES AT NIGHT. THE CUSTOMER ALLEGED INSULIN OVER-DELIVERY. THE CUSTOMER TREATED FOR THE LOW BLOOD GLUCOSE WITH FOOD. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 147 MG/DL AT THE TIME OF THE CALL. TROUBLESHOOTING WAS INITIATED ON THE INSULIN PUMP. THE DRIVE SUPPORT CAP APPEARED NORMAL. INSULIN REPORTEDLY DRIPPED FROM THE END OF THE SET BEFORE THE CUSTOMER CONNECTED TO THEIR SITE. THE RESERVOIR CONTAINED MORE INSULIN THAN WHAT WAS DISPLAYED ON THE STATUS SCREEN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8352944 ↗
• MalfunctionDec 18, 2018Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR HAD AIR BUBBLES. THE CUSTOMER¿S BLOOD GLUCOSE WAS 213 MG/DL AT THE TIME OF THE INCIDENT AND CURRENT BLOOD GLUCOSE WAS 165 MG/DL. THE CUSTOMER WAS INSTRUCTED TO DISCONNECT AT THE QUICK RELEASE AND PRIME UNTIL THE AIR BUBBLES WERE NO LONGER VISIBLE. THE CUSTOMER WAS UNABLE TO REMOVE THE AIR BUBBLES AND WAS INSTRUCTED TO CHANGE THE SET; THE AIR BUBBLES DID NOT PERSIST AFTER THE SET CHANGE. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8172723 ↗
• MalfunctionDec 13, 2018Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR HAD AIR BUBBLE ANOMALY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 275 MG/DL AT THE TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE LEVEL WAS 182 MG/DL. CUSTOMER¿S OTHER BLOOD GLUCOSE LEVEL WAS 205 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER STATED THAT THE APPROXIMATE SIZE OF AIR BUBBLES WAS 1 QUARTER INCH. CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER WAS COMPLETED THE TROUBLESHOOT. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8159147 ↗
• InjuryDec 10, 2018Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF OVER 300 MG/DL. CUSTOMER¿S OTHER BLOOD GLUCOSE LEVEL WAS 215 MG/DL AT THE TIME OF CALL. CUSTOMER DID NOT PROVIDE DETAILS REGARDING SYMPTOMS AND TREATMENT OF THEIR HIGH BLOOD GLUCOSE EPISODES. CUSTOMER ALSO REPORTED THAT THE RESERVOIR HAD AIR BUBBLE ANOMALY. CUSTOMER STATED THAT THERE WAS AIR BUBBLE IN THE RESERVOIR ABOUT 1/8 INCH. CUSTOMER TROUBLESHOOT WAS NOT PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8145559 ↗
• InjuryDec 3, 2018Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE AIR BUBBLES WAS PRESENT ON THE TOP OF THE RESERVOIR. CUSTOMER ALSO REPORTED THEY EXPERIENCED HYPERGLYCEMIA. CUSTOMER BLOOD GLUCOSE VALUES WERE 343 MG/DL, 251 MG/DL AND 354 MG/DL. THE APPROXIMATE SIZE OF AIR BUBBLES WAS THE SIZE OF A PEA. CUSTOMER WAS NOTICED AIR BUBBLES DURING THERAPY. CUSTOMER DID NOT WANT TO COMPLETE TROUBLESHOOT FOR AIR BUBBLES. CUSTOMER WAS TREATED WITH BOLUS. CUSTOMER DID NOT ALLEGE PUMP WAS UNDER DELIVERING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Bruise/Contusion; Hyperglycemia

  MAUDE report 8123883 ↗
• MalfunctionNov 30, 2018Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND NO DELIVERY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 109 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE INSULIN PUMP. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS AND WAS ABLE TO COMPLETE THE REWIND PROCESS. CUSTOMER ALSO REPORTED AIR BUBBLES IN THE RESERVOIR. CUSTOMER REPORTED THAT THEY DID NOT ALLOW FOR INSULIN TO WARM TO ROOM TEMPERATURE PRIOR TO FILLING THE RESERVOIR. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8118672 ↗
• MalfunctionNov 26, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR HAD LEAK IN PAST 2ND O-RING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT LEAK OCCURRED DURING FILLING RESERVOIR. THE CUSTOMER STATED THAT THE INSULIN PUMP RECEIVED PUMP ERROR ALARM. SELF TEST PASSED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8100776 ↗
• MalfunctionNov 23, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED BY THE CUSTOMER'S PARENT THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 84 MG/DL AT THE TIME OF THE INCIDENT. THE CALLER NOTICED IN THE BOLUS HISTORY THAT THE CUSTOMER WAS GETTING A BOLUS EVERY HALF HOUR. THE CUSTOMER WAS AT 59 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER USED FOOD TO TREAT. THE CALLER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER REPORTED SEVERAL UN-PROGRAMMED BOLUSES. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE CALLER ALSO REPORTED AN ISSUE WITH THEIR METER DISPLAY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8099320 ↗

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