MAUDE MDR 2166477

MDR report key
2166477
Report number
1651093-2006-00015
Event key
0
Event type
3
Date received
2006-04-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
DAVID CROUSER
Address
800 NORTH RESEARCH PARKWAY SUITE 370 OKLAHOMA CITY OK 73104 US
Phone
405-405-4052
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DR-3DTNONENFGY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-04-2501. O

Event Narratives#

D

Patient 1

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 WITHOUT 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. NO PATIENTS WERE INJURED. THE SOFTWARE WAS FIXED TO PRECLUDE ANY RECURRENCE OF THIS ERROR. 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.