FDA Adverse Event Malfunction Summary report: N

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

MDR report key: 16690587 · Received April 6, 2023

Report

Report Number: 3013756811-2023-49566
Event Type: Malfunction
Date Received: April 6, 2023
Date of Event: March 19, 2023
Report Date: April 6, 2023
Manufacturer: TANDEM DIABETES CARE
Product Code: QFG
UDI-DI: 00389152000077
PMA / PMN Number: K201214
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PER TANDEM USER GUIDE: ALWAYS REMOVE ALL AIR BUBBLES FROM THE CARTRIDGE BEFORE BEGINNING INSULIN DELIVERY. ENSURE THERE ARE NO AIR BUBBLES WHEN DRAWING INSULIN INTO THE FILLING SYRINGE, HOLD THE PUMP WITH THE WHITE FILL PORT POINTED UP WHEN FILLING THE TUBING, AND ENSURE THAT THERE ARE NO AIR BUBBLES IN THE TUBING WHEN FILLING. AIR IN THE SYSTEM TAKES SPACE WHERE INSULIN SHOULD BE AND CAN AFFECT INSULIN DELIVERY.

Description of Event or Problem · 0

IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT (TTS) AND NO ISSUES WERE IDENTIFIED. CUSTOMER CHANGED THE PUMP SUPPLIES AND SUCCESSFULLY RESUMED INSULIN THERAPY. REPORTEDLY, THE CUSTOMER WAS NOT REMOVING THE CARTRIDGE AIR. TANDEM TECHNICAL SUPPORT INFORMED CUSTOMER THAT NOT REMOVING THE CARTRIDGE AIR IS OFF LABEL PER THE USER GUIDE. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 200-215 MG/DL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1755384	T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY	ALTERNATE CONTROLLER ENABLED INFUSION PUMP	QFG	TANDEM DIABETES CARE	1002717		00389152000077

Patients

Seq	Age	Sex	Outcome	Treatment
1	26 YR	Female		INFUSION SET: AUTOSOFT XC