FDA Adverse Event Malfunction Summary report: N

ACCU-CHEK SPIRIT CARTRIDGE

MDR report key: 1811141 · Received August 13, 2010

Report

Report Number: 2183996-2010-01603
Event Type: Malfunction
Date Received: August 13, 2010
Date of Event: July 16, 2010
Report Date: July 16, 2010
Manufacturer: ROCHE INSULIN DELIVERY SYSTEMS INC.
Product Code: LZG
PMA / PMN Number: K060876
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

ON (B)(6) 2010, PT REPORTED "I AM JUST SITTING HERE LOOKING AT THE PUMP AND NOTICED SOMETHING." PT STATED IT LOOKED LIKE SOMETHING WAS LEAKING IN HIS INFUSION DEVICE. VERIFIED PT IS REFERRING TO CONDENSATION INSIDE OF THE CARTRIDGE COMPARTMENT. VERIFIED THERE IS NOT A LOT OF INSULIN AND IT IS ONLY CONDENSATION. HAD PT REMOVE THE INSULIN CARTRIDGE FROM THE INFUSION DEVICE. PT REPORTED THERE IS CONDENSATION AT THE BOTTOM OF THE INSULIN CARTRIDGE, UNDER THE PLUNGER. PT STATED HE CAN SMELL THE INSULIN AND IT SEEMS LIKE THE INSULIN IS LEAKING FROM BELOW THE PLUNGER. PT REPORTED HE INSPECTED THE INFUSION DEVICE AND VERIFIED THAT THERE IS CONDENSATION FROM THE CARTRIDGE LEAKING. ADVISED PT TO TAKE A COTTON SWAB TO CLEAN OUT THE CONDENSATION. VERIFIED PT IS NOT REUSING CARTRIDGES. PT STATED THE INSULIN CARTRIDGE HAS BEEN IN USE ABOUT 4 DAYS. PT REPORTED HE JUST CHANGE THE INFUSION ADAPTER 4 DAYS AGO. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCU-CHEK SPIRIT CARTRIDGE	INSULIN INFUSION PUMP CARTRIDGE	LZG	ROCHE INSULIN DELIVERY SYSTEMS INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR			INSULIN INFUSION SET\| INSULIN