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U.S. Department of Health and Human Services

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

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DATA INNOVATIONS LLC INSTRUMENT MANAGER SOFTWARE BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES Back to Search Results
Model Number 8.15.10
Device Problem Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2018
Event Type  Malfunction  
Event 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.

 
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Brand NameINSTRUMENT MANAGER SOFTWARE
Type of DeviceBLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
Manufacturer (Section D)
DATA INNOVATIONS LLC
120 kimball ave, suite 100
south burlington VT 05403
Manufacturer (Section G)
DATA INNOVATIONS LLC
120 kimball ave suite 100
south burlington VT 05403
Manufacturer Contact
heather hogan
120 kimball ave suite 100
south burlington, VT 05403
8026582850
MDR Report Key7421388
MDR Text Key105405001
Report Number1225673-2018-00001
Device Sequence Number1
Product Code MMH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberBK120051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation MEDICAL TECHNOLOGIST
Remedial Action Recall
Type of Report Initial
Report Date 04/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator MEDICAL TECHNOLOGIST
Device MODEL Number8.15.10
Device Catalogue NumberIMB02815
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/27/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1225673-04/09/2018-001-C

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