Description of Event or Problem · 0
SUBJECT: MEDICAL DEVICE FAILURE TRIGGERING HYPERGLYCEMIC EVENTS -- URGENT REVIEW REQUIRED (TANDEM T:SLIM X2) DEVICE NAME: TANDEM T:SLIM X2 INSULIN PUMP DEVICE TYPE: CONTINUOUS SUBCUTANEOUS INSULIN INFUSION (CSII) MANUFACTURER: TANDEM DIABETES CARE, INC. PATIENT HARM POTENTIAL: YES -- RECURRING UNSAFE HYPERGLYCEMIA DUE TO SYSTEM BEHAVIOR RISK PROFILE: HIGH, WITH LATENT THREAT TO CRITICAL USER GROUPS REPORT SUMMARY: THIS IS AN URGENT REPORT OF A LATENT SAFETY DEFECT BUILT INTO THE TANDEM T:SLIM X2 INSULIN PUMP THAT PRESENTS PREDICTABLE RISK OF HARM TO INSULIN-DEPENDENT PATIENTS -- PARTICULARLY THOSE WITH NON-STANDARD COGNITIVE, NEUROLOGICAL, OR CIRCADIAN REGULATION PATTERNS. SPECIFICALLY, THE DEVICE INCLUDES A NON-DEFEATABLE 12-HOUR INACTIVITY AUTO-SHUTDOWN, WHICH HALTS BASAL INSULIN DELIVERY REGARDLESS OF PATIENT CONDITION, GLUCOSE LEVEL, OR ACTIVE INFUSION STATUS. THIS FEATURE IS NOT USER-CONFIGURABLE AND OFFERS NO EXEMPTION PATH, OVERRIDE MECHANISM, OR INTELLIGENT CONTEXT AWARENESS. THE FEATURE PUNISHES NORMAL USER BEHAVIOR -- INCLUDING DEEP SLEEP, LONG WORK SHIFTS, AND NEURODIVERGENT BEHAVIOR PATTERNS -- BY TERMINATING INSULIN FLOW, RESULTING IN REPEATED HYPERGLYCEMIC EPISODES. THIS CONSTITUTES A SYSTEM-LEVEL BEHAVIORAL TRAP, NOT A PATIENT NONCOMPLIANCE ISSUE. SYSTEMIC IMPACT: THE PUMP INTRODUCES SELF-INDUCED DEVICE ERROR WITH NO PHYSIOLOGICAL JUSTIFICATION HYPERGLYCEMIA RESULTING FROM FORCED SHUTDOWN CARRIES COMPOUNDED RISK OF DKA, HOSPITALIZATION, AND GLUCOSE VARIABILITY TANDEM OFFERS NO PATH TO DISABLE OR EXTEND THE 12-HOUR CUTOFF FOR MEDICALLY STABLE, HIGH-AWARENESS USERS DEVICE IS INCOMPATIBLE WITH 24-HOUR PATIENT LIFE REALITIES, MAKING IT A SILENT FAILURE MODE FOR THE UNAWARE REQUEST FOR IMMEDIATE ACTION: FLAG TANDEM'S FIRMWARE AND UI LOGIC FOR REVIEW UNDER MEDICAL RISK BEHAVIOR DESIGN INVESTIGATE THE AUTOMATED LOGIC TREE THAT EXECUTES LIFE-CRITICAL SHUTDOWNS ABSENT PHYSIOLOGICAL TRIGGERS REQUIRE A USER OVERRIDE OR AUTHENTICATED EXTENSION PROTOCOL CLASSIFY CURRENT DESIGN AS POTENTIALLY DISCRIMINATORY AGAINST NEUROCOGNITIVELY IMPAIRED POPULATIONS THIS IS NOT A FEATURE -- IT IS A PREDICTABLE FAILURE CYCLE EMBEDDED INTO A CLASS II MEDICAL DEVICE USED TO MANAGE A LIFE-CRITICAL CONDITION. THE SYSTEM PRIORITIZES LEGAL INSULATION OVER PATIENT SAFETY. LET THIS SUBMISSION TRIGGER THE CORRECT REVIEW PATH.