MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-09-05 for DR-3DT * manufactured by Inoveon Corporation.
[694244]
A recent dr-3dt software release produced inaccurate iscore recommendation reports at four locations around the country. The software resides on a central server accessed from the four sites. The inaccurate recommendation reports would likely contribute to serious eye injury if the malfunction were to recur without being detected. Forty-five patients (see continuation page for listing) could have been affected by the inaccurate iscore reports. Human intervention prevented this occurrence. The software was fixed to preclude any recurrence of this error. No patients were injured.
Patient Sequence No: 1, Text Type: D, B5
[7811009]
The inaccurate iscore recommendation reports were produced using a new automated iscore printing function released as software version 1. 5. The iscore reports generated by this new automation feature, where a revision to the original recommendation was made by the triage manager, printed the original recommendation was made by the triage manager, printed the original recommendation instead of the triage manager's revised recommendation. The query used by the automated iscore software process accessed the "recommendation" data field from the analysis table instead of the "recommendation" data field from the evalsumaudit table in the dr-3dt database. Through examination of the software queries, inoveon confirmed the query used to obtain evaluation summary data refrenced the original recommendation data table even when a revised recommendation was available in another table. Auto printing of iscore reports was suspended until a software modification was developed and tested. After successful validation tests were completed, the software fix was implemented and auto print feature enabled.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651093-2006-00001 |
| MDR Report Key | 889127 |
| Report Source | 07 |
| Date Received | 2006-09-05 |
| Date of Report | 2006-04-07 |
| Date of Event | 2006-01-30 |
| Date Mfgr Received | 2006-03-08 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2007-08-06 |
| 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 | 0 |
| Manufacturer Contact | DAVID CROUSER |
| Manufacturer Street | 800 NORTH RESEARCH PARKWAY SUITE 370 |
| Manufacturer City | OKALAHOMA CITY OK 731043698 |
| Manufacturer Country | US |
| Manufacturer Postal | 731043698 |
| Manufacturer Phone | 4052712095 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DR-3DT |
| Generic Name | DIABETIC RETINOPATHY PHOTOGRAPHY DEVICES |
| Product Code | NFG |
| Date Received | 2006-09-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | S/W VERSION 1.5 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 866615 |
| Manufacturer | INOVEON CORPORATION |
| Manufacturer Address | * OKLAHOMA CITY OK * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-09-05 |