MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-10-27 for IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08) IMPAX CV 2.08 manufactured by Agfa Healthcare Corp.
[21937485]
Agfa submitted mdr report #1225058-2010-00001 to the fda on june 7, 2010 for a site in the us. A 12th occurrence is being reported for the same issue/same device: impax cv results management administration tool (rmat). This is an internal discovery determined during the implementation of the associated problem correction plan, rmat verification, as reported in fda z-2112-10. Within this 12th occurrence are 2,828 different study dates from years 2005 to october 2014, in which an individual mdr report will be submitted for each associated study date and medical record number (mrn). Currently, 10,266 reports contain this incorrect finding information.
Patient Sequence No: 1, Text Type: D, B5
[22218785]
An agfa clinical analyst performed a retro-analysis and reported the findings to agfa service and agfa product quality manager. Agfa's investigation into this occurrence of rmat customization has revealed that this specific change had the potential to introduce clinical inaccuracies in patient reports. Specifically: echo r. 1. 1. 1 - incorrect measurement sentence import: the sentence "the aortic valve area, by peak velocities is calculated at ( ) cm2. " generates a measurement from aortic valve cross sectional area, not peak velocity. The potential impact of this incorrect measurement sentence is: incorrect aortic valve area method will be displayed in the sentence with a potential of under or over estimating the aortic valve area by peak velocity. Or the value may not be presented in a sentence, which creates the potential for misdiagnosis of disease status. A reportable correction is underway for this issue and has been reported to the fda via reference #z-2112-10. Agfa will follow the rmat post market verification work instructions to correct the sentence finding. Any further investigation for the site described in this report will be documented in the ongoing cfr part 806 reporting. The specific study date and medical records number/s for this mdr are: mrn: (b)(6); study date: (b)(6) 2009.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1225058-2014-01314 |
| MDR Report Key | 4456211 |
| Report Source | 07 |
| Date Received | 2014-10-27 |
| Date of Report | 2014-10-29 |
| Date of Event | 2014-10-03 |
| Date Mfgr Received | 2014-10-03 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2015-02-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. DEBORAH HUFF |
| Manufacturer Street | 10 SOUTH ACADEMY ST |
| Manufacturer City | GREENVILLE SC 29601 |
| Manufacturer Country | US |
| Manufacturer Postal | 29601 |
| Manufacturer Phone | 8644211754 |
| Single Use | 0 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08) |
| Generic Name | PICTURE ARCHIVING AND COMMUNICATION |
| Product Code | LLX |
| Date Received | 2014-10-27 |
| Model Number | IMPAX CV 2.08 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AGFA HEALTHCARE CORP |
| Manufacturer Address | 1 CROSSWIND RD. MISQUAMICUT RI 02891 US 02891 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-27 |