MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. CONTROL IQ SOFTWARE (FOR TANDEM DIABETES PUMPS); INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

Catalog Number SW12097

Device Problems Inaccurate Delivery (2339); Application Program Problem (2880)

Patient Problem Hypoglycemia (1912)

Event Date 05/25/2022

Event Type  Injury  

Event Description

Tandem diabetes pump #90649752 using tandem control iq software firmware 2.27.2.103, hardware revision 0xff, ble hardware id 16705, software number (b)(4).Control iq software predicted a blood sugar to exceed 180 mg/dl and delivered a corrected bolus of insulin (novolog).The problem occurred when the glucose level begin to drop before the insulin was delivered; and the resulting bolus resulted in a rapidly falling blood sugar which fell to 57 mg/dl before corrective action could be taken.This problem with the control iq software has happened at least 5 times since (b)(6) 2022.Low blood sugar was confirmed with finger stick blood glucose.Fda safety report id# (b)(4).

• Brand Name: CONTROL IQ SOFTWARE (FOR TANDEM DIABETES PUMPS)
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.
• MDR Report Key: 14547358
• MDR Text Key: 293160242
• Report Number: MW5109969
• Device Sequence Number: 1
• Product Code: QJI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: SW12097
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2022
• Patient Sequence Number: 1
• Treatment: ALEVE; BENZAPRIL; METROPROLOL; MULTIVITAMIN; NEFEDIPINE; NOVOLOG; NOVOLOG; SIMVASTATIN; TANDEM DIABETES PUMP; TRAZADONE; VITAMIN D
• Patient Outcome(s): Disability
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White