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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 8.13.05
Device Problem Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/26/2018
Event Type  Malfunction  
Manufacturer Narrative

Software affected: instrument manager v 8. 13. 05. Issue: (b)(4) instruments at two different sites with same rack numbers overwrote patient data (erroneous results). Became aware date: 15 mar 2018. Issue details: duplicate rack numbers at different sites led to overwriting patient data with erroneous results. Once caught, (b)(4) got rid of any duplicate racks as that was the cause of this issue. The results were routed through instrument manager. Customer has not provided a patient impact statement. The problem was reported to data innovations by the distributor ((b)(4)). This was a user error, determined not to be a data innovations instrument manager product malfunction. Data innovations has not been able to determine if this same user error occurred on results for other patients and, if it did, what the patient impact was. Data innovations was advised from (b)(4) that (b)(4) will report this incident to regulatory authorities. The end customer is university of (b)(6). Issue magnitude: the user error occurred at only one customer site and was unrelated to the im product. However, the extent of patient impact at that one site has not been determined and customer/distributor has not provided this information to data innovations on request. Patient impact: unknown patient impact. Investigation summary: it was determined that this was not a product malfunction. (b)(4) (di support) spoke with (b)(4) on 29 march 2018. (b)(4) confirmed with the configuration the customer has implemented, they should not have used duplicate rack numbering ranges as the duplicate rack ranges would cause issues like the one reported. Hazard (risk) analysis: there is no hazard in instrument manager associated with this because the user error was related to a sample rack id conflict and not the instrument manager product. Workarounds/mitigations: not applicable root cause (if known at time): user error with another device. (not instrument manager).

 
Event Description

Issue: (b)(4) instruments at two different sites with same rack numbers overwrote patient data (erroneous results). Became aware date: 15 mar 2018; issue details: duplicate rack numbers at different sites led to overwriting patient data with erroneous results. Once caught, (b)(4) got rid of any duplicate racks as that was the cause of this issue. The results were routed through instrument manager. Customer has not provided a patient impact statement. The problem was reported to data innovations by the distributor ((b)(4)). This was a user error, determined not to be a data innovations instrument manager product malfunction. Data innovations has not been able to determine if this same user error occurred on results for other patients and, if it did, what the patient impact was. Data innovations was advised from (b)(4) that (b)(4) will report this incident to regulatory authorities. The end customer is university of (b)(6). Issue magnitude: the user error occurred at only one customer site and was unrelated to the im product. However, the extent of patient impact at that one site has not been determined and customer/distributor has not provided this information to data innovations on request.

 
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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
david russo
120 kimball ave suite 100
south burlington, VT 05403
8026582850
MDR Report Key7426565
MDR Text Key105681228
Report Number1225673-2018-00002
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 DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/12/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator MEDICAL TECHNOLOGIST
Device MODEL Number8.13.05
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/15/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/28/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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