MAUDE Adverse Event Report: DATA INNOVATIONS LLC INSTRUMENT MANAGER; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES, PRODUCT CODE: MMH

Model Number 8.15.10

Device Problem Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

Upon investigation with the facility it was determined that a rule (user facility programed logic) went live in (b)(6) 2022 to resolve an issue with a beckman analyzer sending replicates of test results with the same test code which was incompatible with the labortatory information system (lis).Because the lis was unable to file this properly a rule was written to add a new, unique, test code in order to properly process the results.The rule was tested and validated by the facility prior to it being moved live in (b)(6) 2022.At an unknown time after (b)(6) 2022 the site was able to resolve the issue with the replicate test results on the instrument.At that time the rule became obsolete but was not deactivated.At the time that the incident was reported, when a result was received in the lis that was performed on two different analzers the rule was triggered under the previous condition of all repliactes having the same test code.The rule changed a valid result which made it incorrect.When this occurred the medical technician caught the bad result and it was not released nor did it impact patients.The site immediately stopped testing when this was noticed and started an internal investigation.During the investigation the site noted that they performed look backs and found 36 incorrect results released.The customer does do not have patient impact information as they do not know how many products were sold by their clients and if they were transfused into patients.The customer site does not have the patient impact information as they are a test service for blood donation sites and any recalls would need to be performed by the donation centers and not the facility.Once the result of the error was located the previously active rule was disabled and the site was able to successfully validate the system and restart production.While this is not a malfunction of the instrument manager medical device (rules were working as expected) it is being reported due to the facilites inability to provide a patient impact of the user error.

Event Description

A facility reported on (b)(6) 2022 that results of a syphilis test that were rerun were not being sent correctly to the laboratory information system (lis).During the processing the results were being changed or modified by the system.As a result, 36 erroneous results were released to blood testing centers.Facility was not able to determine if this error resulted in patient harm.

• Brand Name: INSTRUMENT MANAGER
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES, PRODUCT CODE: MMH
• Manufacturer (Section D): DATA INNOVATIONS LLC; 463 mountain view drive; colchester VT 05446
• Manufacturer (Section G): 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: 15218368
• MDR Text Key: 305555310
• Report Number: 1225673-2022-00006
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8.15.10
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1