ISCORE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-04-25 for ISCORE manufactured by .

Event Text Entries

[19207030] A recent dr-3dt software upgrade enabled automatic iscore printing at four locations around the country. The new feature produced some inaccurate iscore recommendation reports. This malfunction would likely contribute to serious eye injury if the malfunction were to recur w/o being detected. This error only occurred using the new automated iscore printing function. Iscore reports printed by the automated printing process, where a revision was made by the triage manager, contained the original recommendation text instead of the revised recommendation. The query used by the automated iscore process used the "recommendation" data field from the analysis table instead of the "recommendation" data field from the evalsumaudit table in the dr-3dt database. Through examination of the software queries, inoveon confirmed the query used to obtain evaluation summary data referenced the original recommendation data table even when a revised recommendation was available in another table. Auto printing of iscore reports was suspended until a software modification was developed and tested. After successful validation tests were completed, the fix was implemented and auto print feature enabled. No patients were injured. The software was fixed to preclude any recurrence of this error.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1651093-2006-00007
• MDR Report Key: 2143970
• Report Source: 07
• Date Received: 2006-04-25
• Date Mfgr Received: 2006-03-08
• Device Manufacturer Date: 2006-02-01
• Date Added to Maude: 2011-07-06
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: DAVID CROUSER
• Manufacturer Street: 800 NORTH RESEARCH PKWY. SUITE 370
• Manufacturer City: OKLAHOMA CITY OK 731043698
• Manufacturer Country: US
• Manufacturer Postal: 731043698
• Manufacturer Phone: 4052718001
• Single Use: 3
• Remedial Action: MA
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ISCORE
• Generic Name: NONE
• Product Code: NFG
• Date Received: 2006-04-25
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2006-04-25