FDA Adverse Event Injury Summary report: N

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

MDR report key: 13110647 · Received December 29, 2021

Report

Report Number: 3013756811-2021-142625
Event Type: Injury
Date Received: December 29, 2021
Date of Event: December 15, 2021
Report Date: December 29, 2021
Manufacturer: TANDEM DIABETES CARE
Product Code: QFG
UDI-DI: 00850006613762
PMA / PMN Number: K201214
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION. THE PUMP USER GUIDE STATES, "TANDEM DIABETES CARE, INC. RECOMMENDS PERIODICALLY CHECKING THE BATTERY LEVEL INDICATOR, CHARGING THE PUMP FOR A SHORT PERIOD OF TIME EVERY DAY (10 TO 15 MINUTES), AND ALSO AVOIDING FREQUENT FULL DISCHARGES."

Description of Event or Problem · 0

IT WAS REPORTED THAT THE CUSTOMER ALLOWED THE PUMP BATTERY TO FULLY DEPLETE DUE TO NOT CHARGING THE BATTERY AND THE PUMP SUBSEQUENTLY SHUT OFF. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 486 MG/DL WITH HIGH KETONES. KETONE LEVELS WERE IDENTIFIED AS LIFE THREATENING BY HEALTH CARE PROVIDER. CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT. REPORTEDLY, THE CUSTOMER EXPERIENCED DIFFICULTY BREATHING, HAD TROUBLE WALKING ALONG WITH NAUSEA. CUSTOMER WAS TREATED WITH INTRAVENOUS INSULIN. CUSTOMER WAS DISCHARGED 2 DAYS LATER WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2012122	T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY	ALTERNATE CONTROLLER ENABLED INFUSION PUMP	QFG	TANDEM DIABETES CARE	1002717		00850006613762

Patients

Seq	Age	Sex	Outcome	Treatment
1	13 YR	Female	Required Intervention\| L\| H	INSULIN: HUMALOG, INFUSION: AUTOSOFT 90