MAUDE Adverse Event Report: DATA INNOVATIONS LLC INSTRUMENT MANAGER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE

Model Number V8.12.10 - V8.14.01

Device Problems Computer Software Problem (1112); Programming Issue (3014); Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4), reported to data innovations late on friday january 15, 2016 in incident (b)(4) that the error codes were all unmapped on the n-mod-ppe configuration.The error codes missing were initially reported after the customer was reviewing results in the lis, and looked into a result that was questionable and found no error flag attached to the result in the lis.When data innovations became aware of the incident on january 18, 2016, investigation into this issue started by reviewing system logs, reports, and configurations.Data innovations' research found that tests resulted on the n-mod-ppe connection before (b)(6) 2016 13:36:12 had error codes processed correctly.However, after this point (for 79 hours) all error codes received from the n-mod-ppe connection were suppressed.The system log showed that a user had imported an error code mapping file into another configuration at this time.The configuration provided by the customer had no error code mapping in it as if someone had cleared the mapping.Data innovations was able to recreate the issue and determined that after importing error code mapping, all mapping for configuration number 105 was cleared.A review of the software code found an issue with the import error code mapping feature that caused all mapping on configuration number 105 to be cleared when importing the file.

Event Description

Importing error code mapping into instrument manager (im) v 8.12.10 and higher may clear another configuration's error code mapping.This would cause results that should be flagged from that configuration to have no error code on results, and it could have an effect on rules that evaluate the error code(s).If customers have a connection that is using configuration number 105, and they are using error code mapping on that configuration; then importing error codes on any other configuration will clear the lis error code mapping for configuration number 105.This may lead to invalid results being sent to the lis.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE
• Manufacturer (Section D): DATA INNOVATIONS LLC; 120 kimball ave suite 100; south burlington VT 05403
• Manufacturer (Section G): DATA INNOVATIONS LLC; 120 kimball ave suite 100; south burlington VT 05403
• Manufacturer Contact: susan rogers-akey ; 120 kimball ave suite 100; south burlington, VT 05403 ; 8022643486
• MDR Report Key: 5442355
• MDR Text Key: 38981725
• Report Number: 1225673-2016-00001
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK120051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V8.12.10 - V8.14.01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2016
• Initial Date FDA Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1