Glucommander NoneRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00860057000305), received between Sep 21, 2016 and Apr 20, 2026 — classified as 2 deaths, 7 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (4 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• DeathApr 20, 2026Inadequate or Insufficient Training; Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH SIGNIFICANT CLINICAL COMPLEXITY WITH PRIOR HISTORY OF HYPOGLYCEMIC EVENTS (HOME REGIMEN INCLUDED MULTIPLE DAILY INJECTIONS OF INSULIN) WAS ADMITTED WITH HYPERGLYCEMIA (>300 MG/DL) ON [ADMISSION DATE UNKNOWN TO GLYTEC]. ON (B)(6) 2026, THE PROVIDER INITIATED GLUCOMMANDER USING WEIGHT-BASED DOSING, (THE PATIENT'S WEIGHT WAS 58.9 KG), RESULTING IN INITIAL ORDERS OF 15 UNITS BASAL DAILY AND 5 UNITS LISPRO PER MEAL. THE INITIAL BASAL AND PRANDIAL DOSES WERE DETERMINED BY THE PROVIDER AND THE ORDERS WERE ENTERED IN THE EHR. PATIENT RECEIVED 1 UNIT CORRECTION AT INITIATION AND THE 15-UNIT BASAL AS ORDERED; PATIENT DID NOT RECEIVE ANY MEALTIME INSULIN. WITHIN APPROXIMATELY 12-18 HOURS, PATIENT EXPERIENCED SEVERE HYPOGLYCEMIA, REQUIRED RESUSCITATIVE TREATMENT, AND EXPERIENCED RECURRENT HYPOGLYCEMIC EPISODES. PATIENT EXPIRED APPROXIMATELY 30 HOURS AFTER THE INITIAL DOSING EVENT. CUSTOMER NOTED THAT THE PATIENT'S DEATH WAS NOT ATTRIBUTED SOLELY TO HYPOGLYCEMIA BUT OCCURRED DURING A CRITICAL ILLNESS WINDOW.

  Patient problems: Hypoglycemia

  MAUDE report 24925448 ↗
• MalfunctionOct 24, 2024Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  GLYTEC RECEIVED A CALL FROM A HEALTHCARE PROFESSIONAL WHO WAS ATTEMPTING TO MODIFY A PATIENT'S RECOMMENDED BASAL DOSAGES AND DOSE FREQUENCY. UPON DOING SO, THE NEW BASAL DOSE RECOMMENDATION WAS HIGHER THAN THE NURSE EXPECTED. THIS DOSE WAS NOT ADMINISTERED TO THE PATIENT AND NO ADVERSE EVENTS NECESSITATING MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20526568 ↗
• MalfunctionJul 7, 2019Decoupling; Connection Problem; Decoupling; Connection Problem

  GLUCOMMANDER EXPERIENCED AN INTERRUPTION IN THE FLOW OF DATA FROM AN EXTERNAL GLUCOSE DATA SOURCE FOR A BRIEF PERIOD OF TIME. ONCE CONNECTION WAS RE-ESTABLISHED, DATA ANOMALIES WERE OBSERVED. BEFORE THE ANOMALIES WERE CORRECTED, DOSE RECOMMENDATIONS WERE GENERATED FOR SIX (6) PATIENTS. THE ANOMALIES HAD NO IMPACT ON THE APPROPRIATENESS OF THE DOSE RECOMMENDATIONS; THEREFORE, THERE WAS NO RISK TO THESE PATIENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8766020 ↗
• MalfunctionJan 31, 2019Computer Software Problem; Data Problem; Patient Data Problem; Computer Software Problem; Data Problem; Patient Data Problem

  GLUCOMMANDER INTEGRATION WITH THE ELECTRONIC MEDICAL RECORD (EMR) MAY CAUSE INCORRECT PATIENT TO LOAD. ON VERY RARE INSTANCES, A SYSTEM ERROR MAY CAUSE SMARTCLICK REQUESTS TO OVERLAP AND IDENTIFY THE WRONG PATIENT FOR A TREATMENT REQUEST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8293927 ↗
• DeathJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A CRITICALLY ILL HOSPITALIZED PATIENT, WAS STARTED ON GLUCOMMANDER IV. THE PATIENT REACHED TARGET RANGE AND REMAINED IN TARGET FOR APPROXIMATELY 8 HOURS, UPON WHICH A BLOOD GLUCOSE OF 292 MG/DL WAS ENTERED BY THE NURSE. BECAUSE OF THE DRAMATIC CHANGE IN BLOOD GLUCOSE LEVELS, GLUCOMMANDER PRESENTED A WARNING TO THE END USER ALERTING THEM THAT THIS BLOOD GLUCOSE WAS SIGNIFICANTLY HIGHER THAN THE PREVIOUS BLOOD GLUCOSE AND ASKING THEM TO CONFIRM THE BLOOD GLUCOSE WAS 292 MG/DL. THE USER ACKNOWLEDGED THE WARNING AND CONFIRMED THE BG AT 292 MG/DL. A SUBSEQUENT BG OF 315 MG/DL WAS ENTERED NEXT, UPON WHICH GLUCOMMANDER ALERTED THE USER THAT THE MAXIMUM INFUSION RATE HAD BEEN REACHED AND TO CONTACT THE PHYSICIAN. A FINAL BG OF 257 MG/DL WAS ENTERED 67 MINUTES LATER, 7 MINUTES PAST THE RECOMMENDED BG CHECK TIME. AFTER THIS FINAL BG WAS ENTERED, THE CUSTOMER STATED THE PATIENT HAD SEIZURES AND A SUBSEQUENT BG READING SHOWED SEVERE HYPOGLYCEMIA WHICH WAS NOT ENTERED INTO GLUCOMMANDER.

  Patient problems: Death; Hypoglycemia; Seizures

  MAUDE report 7630431 ↗
• MalfunctionJan 4, 2018Computer Software Problem; Application Program Problem: Dose Calculation Error; Data Problem; Computer Software Problem; Application Program Problem: Dose Calculation Error; Data Problem

  AFTER A SPLIT TRANSITION, EDITING THE ORDER SET RENDERS A FULL DOSE INSTEAD OF SECOND HALF OF SPLIT DOSE AT NEXT BASAL TIME.

  Patient problems: Hypoglycemia; No Known Impact Or Consequence To Patient

  MAUDE report 7163932 ↗
• MalfunctionNov 30, 2017Computer Software Problem; Application Program Problem: Dose Calculation Error; Data Problem; Computer Software Problem; Application Program Problem: Dose Calculation Error; Data Problem

  AFTER TRANSITION, TRANSITION BASAL DOSE MAY NOT BE ACCOUNTED FOR - PATIENT TRANSITIONING FROM IV TO SUBQ TREATMENT RECEIVES TRANSITIONAL BASAL DOSE VIA "GIVE NOW" SELECTION. AT START OF SUBQ TREATMENT, PROMPT MAY BE PROVIDED TO GIVE FULL BASAL AGAIN.

  Patient problems: Hypoglycemia; No Known Impact Or Consequence To Patient

  MAUDE report 7070153 ↗
• MalfunctionDec 14, 2016Application Program Problem: Dose Calculation Error; Incorrect Software Programming Calculations; Programming Issue; Application Program Problem: Dose Calculation Error; Incorrect Software Programming Calculations; Programming Issue

  A HEALTH CARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED A BG OF 46 MG/DL AND ASKED THAT IT BE INVESTIGATED. UPON REVIEWING THE PATIENT IT WAS NOTED THAT THE I:C RATIO ADJUSTED WITH THE FIRST BG AFTER TRANSITION AS WELL AS ADJUSTING TWICE DURING A "WAITING TO EAT" MEAL.

  Patient problems: Hypoglycemia

  MAUDE report 6173544 ↗
• MalfunctionSep 21, 2016Computer Software Problem; Incorrect Software Programming Calculations; Application Program Problem; Computer Software Problem; Incorrect Software Programming Calculations; Application Program Problem

  GLYTEC DISCOVERED A SOFTWARE ERROR IN THE GLUCOMMANDER APPLICATION THAT AFFECTED BASAL DOSING RECOMMENDATIONS WHEN EDITED USING TWICE DAILY DOSING. AFTER THE EDIT IS PERFORMED THE BASAL DOSE RECOMMENDATION ADJUSTS INCORRECTLY. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5967144 ↗