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

Model Number V8.14.10

Device Problems Loss of Data (2903); Insufficient Information (3190)

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

Event Date 08/01/2018

Event Type  malfunction  

Event Description

The customer reports a specimen id (sid)/patient id (pid) mismatch from an abl80 connection to instrument manager.It was determined that the abl80 instrument was returning a different pid than the ssn provided from (b)(6).There is a configuration option in the abl80 driver where the user can set the patient identifier (social security number, patient id).The site had this configured and was working as expected, then they started getting pid/sid mismatch errors.The configuration was changed to use a different patient identifier, which resulted in the instrument returning one type of patient id when the lis was expecting a different patient id, resulting in the pid/sid mismatch error.Data innovations is trying to determine the root cause of what caused the configuration option to be changed since the user states they did not change it.The site has indicated no patients were harmed due to this issue.

Manufacturer Narrative

Upon further investigation, it was determined this was not a malfunction of instrument manager, it was a user configuration error.No patients were harmed.

Event Description

The customer reports a specimen id (sid)/patient id (pid) mismatch from an abl80 connection to instrument manager.It was determined that the abl80 instrument was returning a different pid than the ssn provided from vista.There is a configuration option in the abl80 driver where the user can set the patient identifier (social security number, patient id).The site had this configured and was working as expected, then they started getting pid/sid mismatch errors.The configuration was changed to use a different patient identifier, which resulted in the instrument returning one type of patient id when the lis was expecting a different patient id, resulting in the pid/sid mismatch error.Data innovations is trying to determine the root cause of what caused the configuration option to be changed since the user states they did not change it.The site has indicated no patients were harmed due to this issue.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE
• Manufacturer (Section D): DATA INNOVATIONS LLC; 120 kimball avenue; suite 100; south burlington VT 05403
• MDR Report Key: 7834728
• MDR Text Key: 118893113
• Report Number: 1225673-2018-00008
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: BK120051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

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: V8.14.10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 08/01/2018
• Supplement Dates FDA Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1