FDA Adverse Event Malfunction Summary report: N

ACCH-CHEK SPIRIT COMBO

MDR report key: 2915351 · Received December 28, 2012

Report

Report Number: 2183996-2012-02075
Event Type: Malfunction
Date Received: December 28, 2012
Date of Event: December 17, 2012
Report Date: December 17, 2012
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: IT
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE INCIDENT OCCURRED OUTSIDE 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

THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. THE DISPLAY WINDOW IS SCRATCHED DUE TO A MECHANICAL IMPACT. THEREFORE, THE DISPLAY IS NO LONGER FULLY READABLE IN THE AREA WHERE THERAPY- RELEVANT INFORMATION IS VISIBLE. THE SCRATCHED DISPLAY CAN LEAD TO MISINTERPRETATION OF INSULIN AMOUNTS. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO A HANDLING ISSUE.

Description of Event or Problem · 1

PATIENT REPORTED THE GLASS ON THE INFUSION DEVICE IS SCRATCHED. PATIENT STATED SHE CANNOT SEE THE DISPLAY WELL. PATIENT REPORTED THE INFUSION DEVICE WORKS BUT SHE HAS A HARD TIME READING THE DATA. PATIENT STATED SHE CAN MISUNDERSTAND THE VALUES. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

Devices

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

Patients

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