FDA Adverse Event Injury Summary report: N

T:SLIM G5 SYSTEM

MDR report key: 7574268 · Received June 6, 2018

Report

Report Number: 3013756811-2018-18716
Event Type: Injury
Date Received: June 6, 2018
Date of Event: April 15, 2018
Report Date: June 6, 2018
Manufacturer: TANDEM DIABETES CARE
Product Code: OYC
PMA / PMN Number: P140015
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

PER THE USER GUIDE: DO NOT REUSE CARTRIDGES OR USE CARTRIDGES OTHER THAN THOSE MANUFACTURED BY TANDEM DIABETES CARE, INC. USE OF CARTRIDGES NOT MANUFACTURED BY TANDEM DIABETES CARE, INC. OR REUSE OF CARTRIDGES MAY RESULT IN OVER DELIVERY OR UNDER DELIVERY OF INSULIN. THIS CAN CAUSE VERY LOW OR VERY HIGH BLOOD GLUCOSE. THE SINGLE-USE DISPOSABLE CARTRIDGE CAN HOLD UP TO 300 UNITS (3.0 ML) OF INSULIN. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CUSTOMER RECEIVED ONGOING, INTERMITTENT INACCURATE FILL ESTIMATES. AS THE EVENTS HAD OCCURRED IN THE PAST, TANDEM TECHNICAL SUPPORT WAS UNABLE TO TROUBLESHOOT TO DETERMINE A POSSIBLE CAUSE. BLOOD GLUCOSE (BG) WAS 550 MG/DL AT ITS HIGHEST. CORRECTIONS VIA THE PUMP AND MANUAL INJECTIONS WERE USED TO ADDRESS BG. REPORTEDLY, ON OCCASION, THE CUSTOMER REUSED THE CARTRIDGES AND FILLED THE CARTRIDGE WITH OVER 300 UNITS OF INSULIN. TANDEM TECHNICAL SUPPORT ADVISED THE CUSTOMER THAT PER THE PUMP LABELING, NOT TO OVERFILL AND NOT TO REUSE THE CARTRIDGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
417513	T:SLIM G5 SYSTEM	CONTINUOUS GLUCOSE MONITOR	OYC	TANDEM DIABETES CARE	1000096

Patients

Seq	Age	Sex	Outcome	Treatment
1	43 YR		Other	INFUSION SET: AUTOSOFT 90, INSULIN: HUMALOG