FDA Adverse Event Malfunction Summary report: N

ACCU-CHEK SPIRIT

MDR report key: 2770104 · Received September 28, 2012

Report

Report Number: 2183996-2012-01483
Event Type: Malfunction
Date Received: September 28, 2012
Date of Event: September 23, 2012
Report Date: April 11, 2013
Manufacturer: ROCHE INSULIN DELIVERY SYSTEMS INC.
Product Code: LZG
PMA / PMN Number: NA
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THIS INCIDENT OCCURRED OUTSIDE OF THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative · 1

PRODUCT WAS RECEIVED ON (B)(4) 2013. THE SOFT COMPONENTS OF THE UP BUTTON ARE WORN DOWN HEAVILY. THEREFORE MOISTURE MAY ENTER THE INSULIN PUMP AND DESTROY THE PUMP ELECTRONICS. THE BUTTONS PASSED THE OPTICAL AND FUNCTIONAL INVESTIGATION SUCCESSFUL AND MEET THE SPECIFICATION. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO CARELESS HANDLING OF THE PRODUCT.

Description of Event or Problem · 1

PT REPORTED THE TICK/MENU BUTTONS ON THE INFUSION DEVICE ARE NOT RESPONDING. PT REMOVED AND RE=INSERTED THE BATTERY; STILL NOT WORKING. PT REPORTED RECEIVING AN E8 (POWER INTERRUPT) ERROR MESSAGE NOW AND IS UNABLE TO TICK TO CONFIRM. NO FURTHER INFORMATION IS AVAILABLE. 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 INFUSION DEVICE FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCU-CHEK SPIRIT		LZG	ROCHE INSULIN DELIVERY SYSTEMS INC.	00700006862	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1				INSULIN INFUSION PUMP\| RELATED ACCESSORIES\| INSULIN