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

Model Number 8.14.10

Device Problem Data Problem (3196)

Patient Problem Insufficient Information (4580)

Event Date 05/22/2022

Event Type  malfunction  

Manufacturer Narrative

A collaborative investigation is being completed by data innovations (manufacturer), roche diagnostics (distributor) and strong memorial hospital (customer) and is in progress at the time of this report.On (b)(6) 2022, data innovations was notified of an incident by a distributor of our product (instrument manager).An initial inquiry was directed at a data innovations distributor regarding instrument manager being backlogged in processing orders, with the queue manager being shown in 'hang' status.Instrument manager appeared to be receiving orders from the laboratory information system (lis), but the orders were unable to be processed.Investigation identified a patient name that contained hundreds of extra characters.When the order for this patient was received by instrument manager, an error in parsing was generated.This parsing error prevented orders from crossing to the lis, caused patient id/specimen id mismatch errors, and prevented orders from being logged in the specimen manager database.Once the patient name issue was resolved, the database index was rebuilt and orders were once again being received from the lis and posted to specimen manager.Review of the archived specimen event log (sel) from the customer did not identify any behavior in instrument manager that caused the lengthy patient name that generated the errors.Therefore, it was determined that this was not a malfunction of instrument manager.The distributor has not received a response from the customer regarding patient harm, and therefore the investigation is ongoing at the time of this report.As additional information is received to complete the investigation, an update to this report will be filed.

Event Description

A representative from the reseller reported on (b)(6) 2022 that a laboratory information system (lis) connection was repeatedly logging an error when attempting to process order requests.This resulted in instrument manager becoming backlogged trying to process orders, orders no longer being sent to and received by the lis, errors being generated related to patient id/specimen id mismatch, and the orders not being logged in the specimen manager database.Investigation determined that this was due to an order with a patient name that contained hundreds of extra characters that was being caught in a loop attempting to process the order.Once the patient name issue was resolved and the database index was rebuilt, orders were once again sent and received by the lis.Therefore, it was determined that this was not a malfunction of instrument manager.Data innovations received a response from the reseller that a patient impact statement has not yet been received from the customer and therefore patient impact has been unable to be determined.The investigation is ongoing at the time of this report.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): DATA INNOVATIONS LLC; 463 mountain view drive; colchester VT 05446
• Manufacturer Contact: sara shaw ; 463 mountain view drive; colchester, VT 05446 ; 8026582850
• MDR Report Key: 14750452
• MDR Text Key: 301845092
• Report Number: 1225673-2022-00005
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2022

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 Model Number: 8.14.10
• Initial Date Manufacturer Received: 05/22/2022
• Initial Date FDA Received: 06/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1