Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0099-2011

SoftWeb version 4.0.4.10.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Date...

SCC Soft Computer / initiated 2006-06-08 / Terminated / root cause: software

SCC Soft Computer began a recall of SoftWeb version 4.0.4.10.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Date: 05/16/2006 on . The reason FDA records is "If a case number is re-used in SoftWeb with SoftPath, the SoftPath case is linked to the original MRN in SoftWeb. This causes SoftPath cases being linked to the wrong patient in SoftWeb. Incorrect results on the patient...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0099-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
SCC Soft Computer
Product
SoftWeb version 4.0.4.10.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Date: 05/16/2006.
Product code
LNX
Reason for recall
If a case number is re-used in SoftWeb with SoftPath, the SoftPath case is linked to the original MRN in SoftWeb. This causes SoftPath cases being linked to the wrong patient in SoftWeb. Incorrect results on the patient with original MRN and no results on the patient with the second MRN (and the reused case number) are displayed in SoftWeb Results Query. SCC Soft Computer issued a Correction for
Root cause tag
software
FDA root cause
Software design
Action
SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to the affected client using SCC Soft Computer's proprietary Task Management System on June 8, 2006. SCC recommended SoftPath/SoftWeb users NOT re-use SoftPath case numbers when cases are cancelled. The generic option setting "Specimen Registration - Standard Settings - Minimum Time to Reactivate Case Number" should be set to "0" so the user is not prompted to reuse the same case number. Client was asked to acknowledge receipt of the task and grant permission to load the required software correction.
Quantity in commerce
1
Distribution
Nationwide Distribution: 1 hospital in Alaska.
Product codes and lots
version 4.0.4.10.1.