INSTRUMENT MANAGER SOFTWARE 8.15.10 IMB02815

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-11 for INSTRUMENT MANAGER SOFTWARE 8.15.10 IMB02815 manufactured by Data Innovations Llc.

Event Text Entries

[105405001] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1225673-2018-00001
MDR Report Key7421388
Report SourceUSER FACILITY
Date Received2018-04-11
Date of Report2018-04-11
Date of Event2018-03-20
Date Mfgr Received2018-04-21
Device Manufacturer Date2017-11-27
Date Added to Maude2018-04-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS HEATHER HOGAN
Manufacturer Street120 KIMBALL AVE SUITE 100
Manufacturer CitySOUTH BURLINGTON VT 05403
Manufacturer CountryUS
Manufacturer Postal05403
Manufacturer Phone8026582850
Manufacturer G1DATA INNOVATIONS LLC
Manufacturer Street120 KIMBALL AVE SUITE 100
Manufacturer CitySOUTH BURLINGTON VT 05403
Manufacturer CountryUS
Manufacturer Postal Code05403
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number1225673-04/09/2018-001-C
Event Type3
Type of Report3

Device Details

Brand NameINSTRUMENT MANAGER SOFTWARE
Generic NameBLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
Product CodeMMH
Date Received2018-04-11
Model Number8.15.10
Catalog NumberIMB02815
OperatorMEDICAL TECHNOLOGIST
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDATA INNOVATIONS LLC
Manufacturer Address120 KIMBALL AVE, SUITE 100 SOUTH BURLINGTON VT 05403 US 05403


Patients

Patient NumberTreatmentOutcomeDate
10 2018-04-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.