FDA Adverse Event Malfunction Summary report: N

T:SLIM G5 SYSTEM

MDR report key: 8765485 · Received July 5, 2019

Report

Report Number: 3013756811-2019-38096
Event Type: Malfunction
Date Received: July 5, 2019
Date of Event: June 14, 2019
Report Date: July 5, 2019
Manufacturer: TANDEM DIABETES CARE
Product Code: OYC
UDI-DI: 00853052007257
PMA / PMN Number: P140015
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CARTRIDGE ALARM (ALARM 30) DURING BASAL DELIVERY. CUSTOMER CHANGED THE CARTRIDGE AND INSULIN WAS RESUMED SUCCESSFULLY. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP WOULD NOT CHARGE DESPITE BEING USING MULTIPLE USB CORDS AND WALL ADAPTERS. THE CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET. REPORTEDLY, THE ALERT CLEARED AND THE PUMP SUCCESSFULLY BEGAN CHARGING AFTER LEAVING THE PUMP PLUGGED INTO THE POWER SOURCE. LASTLY, IT WAS REPORTED TOUCHSCREEN HAD A DELAYED RESPONSE TO PRESSES. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. THE CUSTOMER'S BLOOD GLUCOSE WAS 150-221 MG/DL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
558388	T:SLIM G5 SYSTEM	CONTINUOUS GLUCOSE MONITOR	OYC	TANDEM DIABETES CARE	1000096		00853052007257

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR