MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-09-18 for AMALGA UNIFIED INTELLIGENCE SYSTEM manufactured by Caradigm.
[18528025]
The initial complaint was related to a problem with inappropriate claims data records merge. Records were found to be merging within the claims database, which is due to a hash collision where a duplicate row of data is created as a result of the error. In this application there is no possible risk to health. However, further evaluation indicates that there may be a risk of erroneous information in other clinical applications. Caradigm is still investigating the root cause of the complaint. As such, we have not yet been able to confirm a device malfunction has occurred and are unable to assess the clinical impact. We will submit a follow-up mdr report once our investigation and risk analysis is complete.
Patient Sequence No: 1, Text Type: D, B5
[18679154]
The reported problem is under evaluation. Results and conclusions will be provided in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009662652-2012-00001 |
| MDR Report Key | 2764344 |
| Report Source | 05 |
| Date Received | 2012-09-18 |
| Date of Report | 2012-08-08 |
| Date of Event | 2012-08-08 |
| Date Mfgr Received | 2012-08-13 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2013-01-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 14870 N.E. 31ST WAY |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4254217843 |
| Manufacturer G1 | CARADIGM |
| Manufacturer Street | 500 108TH AVE. NE STE. 300 |
| Manufacturer City | BELLEVUE WA 98004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMALGA UNIFIED INTELLIGENCE SYSTEM |
| Generic Name | R2 SP3 |
| Product Code | LMD |
| Date Received | 2012-09-18 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | R2 SP3 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARADIGM |
| Manufacturer Address | 14870 N.E. 31ST WAY REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-09-18 |