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

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2022

Event Type  malfunction  

Event Description

A facility reported on (b)(6) 2022 that three patients had duplicate test results with a time stamp of (b)(6) 2022 which appear to be results from a cbc test previously performed in mid (b)(6) that were re-sent to the patient chart.

Manufacturer Narrative

Upon investigation with the facility, a total of 208 cbc result messages were transmitted to oncoemr (patient charts) for patients that were not in the office the day the results were posted.Investigation with the instrument vendor determined that the results were for a cbc test performed in mid (b)(6) 2022.Based on the facility configured purge settings, instrument manager purges specimen data after 3 days, therefore no specimen data was available for the date the tests were originally run or for the date the results were re-sent.The facility utilizes a results interface that is connected to the oncoemr through direct connection, and results can only be filed through this connection.Because the oncoemr results interface at the facility is configured to purge result data once it is transmitted to oncoemr, no data is available for analysis.The investigation has been unable to determine if the results were sent directly from the instrument due to no data available for analysis.Data innovations has been unable to determine with certainty if this was a malfunction of instrument manager software.The facility has removed the duplicated cbc results and is not aware of any adverse impact to patients at this time.

• Brand Name: INSTRUMENT MANAGER
• 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: 15713774
• MDR Text Key: 302856592
• Report Number: 1225673-2022-00014
• 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: 11/01/2022

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
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 11/02/2022
• Patient Sequence Number: 1