FDA Adverse Event Malfunction Summary report: N

ACCU-CHEK SPIRIT COMBO

MDR report key: 2896359 · Received December 5, 2012

Report

Report Number: 2183996-2012-01928
Event Type: Malfunction
Date Received: December 5, 2012
Date of Event: December 4, 2012
Report Date: April 23, 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: NL
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

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

Additional Manufacturer Narrative · 1

CONCLUSION THE COMPLAINT CANNOT BE VERIFIED DUE TO CARELESS HANDLING OF THE PRODUCT. RESULT THE SOFTCOMPONENTS OF THE UP BUTTON ARE LACERATED. THE DAMAGES DID NOT INFLUENCE THE INSULIN PUMP FUNCTIONS. THE UP BUTTON PASSED THE FUNCTIONAL INVESTIGATION AND COMPLIES WITH THE SPECIFICATION. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO CARELESS HANDLING OF THE PRODUCT.

Description of Event or Problem · 1

ON (B)(6) 2012, IT WAS REPORTED THAT THE BOLUS BUTTONS ON THE PT'S INFUSION DEVICE ARE VERY HARD TO PRESS. THE PT STATED THAT THE BUTTON STILL WORK BUT THE PT NO LONGER HAS 100% CONFIDENCE IN THE DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCU-CHEK SPIRIT COMBO		LZG	ROCHE INSULIN DELIVERY SYSTEMS INC	00700006863	NA

Patients

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