MAUDE Adverse Event Report: DATA INNOVATIONS LLC INSTRUMENT MANAGER; CALCULATORCALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE, PRODUCT CODE JQP

Model Number 8.13.03

Device Problem Installation-Related Problem (2965)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2022

Event Type  malfunction  

Event Description

A facility reported on 15jul2022 that instrument manager was not ordering auto dilutions on test results and the facility has to manually order the dilutions.Additionally, the facility indicated that dilutions were not being held in instrument manager but were instead being auto verified and sent directly to the laboratory information system (lis).

Manufacturer Narrative

Upon investigation with the facility it was determined that rules (user facility programmed logic) were functioning as expected but the programming of those rules was not in alignment with the expectation of the facility.For example, rules were programmed to look for specific error codes to run dilutions.In instances where those error codes were present with the test results the rules were functioning as expected by the facility.While the rule was functioning as expected, when the error code was not present the dilutions were not being run; this was not the intent of the facility.Because the rules were functioning as programmed this is not a malfunction of the system.Data innovations has suggested to the facility that a review of all rules within the system be completed to ensure that they are all programmed correctly to achieve the results desired by the facility.While this is not a malfunction of the insturment manager medical device (rules were working as programmed) it is being reported due to the facilities inability to provide a patient impact of the user error.

• Brand Name: INSTRUMENT MANAGER
• Type of Device: CALCULATORCALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE, PRODUCT CODE JQP
• 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: 15218897
• MDR Text Key: 305053139
• Report Number: 1225673-2022-00007
• 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: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8.13.03
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1