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

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.

Manufacturer Narrative

Software affected: instrument manager v 8.13.05.Issue: roche 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, roche 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 (roche).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 roche that roche will report this incident to regulatory authorities.The end customer is (b)(6) (roche) 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)(6) (di support) spoke with (b)(6) of roche support on 29 march 2018.(b)(6) 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/mitigation's: not applicable root cause (if known at time): user error with another device.(not instrument manager).Update 25 april 2018: data innovations had further correspondence with mr.(b)(6) (the distributor) on 12 april 2018.Mr.(b)(6) confirmed that the user error caused patient data (typically demographic data) to be overwritten but not test data (results).Mr.(b)(6) further confirmed that no patients were treaded with the incorrect data.

Event Description

Issue: roche 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, roche 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 (roche).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 roche that roche will report this incident to regulatory authorities.The end customer is university of california san diego medical center hillcrest (roche) 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.Update 25 april 2018: data innovations had further correspondence with mr.(b)(6) (the distributor) on 12 april 2018.Mr.(b)(6) confirmed that the user error caused patient data (typically demographic data) to be overwritten but not test data (results).Mr (b)(6)further confirmed that no patients were treaded with the incorrect data.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): DATA INNOVATIONS LLC; 120 kimball ave suite 100; south burlington VT 05403
• MDR Report Key: 7426565
• MDR Text Key: 105681228
• Report Number: 1225673-2018-00002
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• PMA/PMN Number: BK120051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Model Number: 8.13.05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1