MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-04-12 for INSTRUMENT MANAGER SOFTWARE 8.13.05 manufactured by Data Innovations Llc.
[105681228]
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).
Patient Sequence No: 1, Text Type: N, H10
[105681229]
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 Sequence No: 1, Text Type: D, B5
| Report Number | 1225673-2018-00002 |
| MDR Report Key | 7426565 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-04-12 |
| Date of Report | 2018-04-25 |
| Date of Event | 2018-02-26 |
| Date Mfgr Received | 2018-03-15 |
| Device Manufacturer Date | 2016-01-28 |
| Date Added to Maude | 2018-04-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID RUSSO |
| Manufacturer Street | 120 KIMBALL AVE SUITE 100 |
| Manufacturer City | SOUTH BURLINGTON VT 05403 |
| Manufacturer Country | US |
| Manufacturer Postal | 05403 |
| Manufacturer Phone | 8026582850 |
| Manufacturer G1 | DATA INNOVATIONS LLC |
| Manufacturer Street | 120 KIMBALL AVE SUITE 100 |
| Manufacturer City | SOUTH BURLINGTON VT 05403 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 05403 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSTRUMENT MANAGER SOFTWARE |
| Generic Name | BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES |
| Product Code | MMH |
| Date Received | 2018-04-12 |
| Model Number | 8.13.05 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATA INNOVATIONS LLC |
| Manufacturer Address | 120 KIMBALL AVE SUITE 100 SOUTH BURLINGTON VT 05403 US 05403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-12 |