FDA Adverse Event Malfunction Summary report: N

D-TRON PLUS

MDR report key: 3781081 · Received April 30, 2014

Report

Report Number: 1823260-2014-03112
Event Type: Malfunction
Date Received: April 30, 2014
Date of Event: April 3, 2014
Report Date: April 30, 2014
Manufacturer: ROCHE DIAGNOSTICS
Product Code: LZG
PMA / PMN Number: NA
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE EVENT OCCURRED IN (B)(4). CONCLUSION: THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. RESULT THE CHECK-BUTTON IS DAMAGED AND DEFECT THROUGH MISUSE. THE CHECK-BUTTON WAS DAMAGED BY A POINTY OBJECT WHICH RESULTED IN A FAULTY SNAP DOME. THEREFORE THE CHECK-BUTTON IS ALWAYS ACTIVE. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISUSE OF THE PRODUCT BY THE CUSTOMER. THERE IS NO INDICATION THE PRODUCT MALFUNCTIONED DUE TO ANY MATERIAL NONCONFORMANCE OR OTHER ERROR BY ROCHE. THE INVESTIGATION DETERMINED THE RETURNED PRODUCT WAS DAMAGED WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT AS DESCRIBED IN THIS CASE. THERE IS NO INDICATION THE PRODUCT'S DAMAGE OCCURRED DUE TO ANY MISTAKE OR NONCONFORMANCE OF MATERIALS WHILE UNDER CONTROL OF THE MANUFACTURER. THE PRODUCT WAS ACCIDENTLY DAMAGED DURING USE AND HANDLING AFTER IT LEFT THE CONTROL OF THE MANUFACTURER.

Description of Event or Problem · 1

PATIENT REPORTED THE CONFIRM BUTTON ON THE INFUSION DEVICE CANNOT BE PRESSED. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REPORT NEEDING 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
259906	D-TRON PLUS	INSULIN INFUSION PUMP	LZG	ROCHE DIAGNOSTICS	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	071 YR