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

Model Number	8.15.10
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Using the "insert coded entry" action in the test or run worksheet may result in an invalid code entered into the coded entry field.The released tests could go out with incorrect results if lab tech doesn't notice the coded entry changed.When using "insert coded entry" action from the command bar an entry selected from the insert coded entry screen may update the test or run worksheet coded entry field, but when you save or click in any other cell in the grid it changes the entry to a different coded entry value.This issue occurs under the following conditions assuming coded entries are being used in the test or run worksheet: user must be in the test worksheet or run worksheet.Note: this issue does not occur when user is in the specimen worksheet, using a test worksheet only view (i.E.No fields visible in specimen worksheet), or using manual results entry or cell counter.User must have the cursor in a coded entry field (patient comment(s), specimen reviewer comment(s), specimen comment(s), result, test reviewer comment(s) or test comment(s)).Note: the cursor must be in the field and in "edit mode" (i.E.The cursor will be flashing).This issue will not occur if the coded entry field is selected but it is not in edit mode.(i.E.Using keyboard to select the cell or click in the cell and press esc key) user must select the "insert coded entry" action from the command bar in sm workspace or use a hot-key to perform the "insert coded entry" action.Note: this issue does not occur when selecting "insert coded entry" from right-click menu, selecting a coded entry from the dropdown list, typing in a coded entry directly into the cell, or using the edit comments action.The text returned from the insert coded entry screen must match an individual entry in the coded entry dropdown list.If free-text is entered that does not match a code in the dropdown, the issue does not occur.Likewise, if multiple codes are selected and returned, the text in the coded entry field will not match an individual dropdown entry, and this issue does not occur.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Common Device Name: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): DATA INNOVATIONS LLC; 120 kimball ave, suite 100; south burlington VT 05403
• MDR Report Key: 7421388
• Report Number: 1225673-2018-00001
• Device Sequence Number: 723273
• Product Code: MMH
• UDI-Device Identifier: B180IMB028150
• UDI-Public: +B180IMB028150/$$78151007/16D20170928K
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: BK120051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Medical Technologist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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
• Operator of Device: Medical Technologist
• Device Model Number: 8.15.10
• Device Catalogue Number: IMB02815
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1225673-04/09/2018-001-C
• Patient Sequence Number: 1