MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-12-12 for IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08) IMPAX CV 2.08 manufactured by Agfa Healthcare Corp.
[20372979]
Agfa submitted mdr report #1225058-2010-00001 to the fda on june 7, 2010, for a site in the us. A 14th 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 occurrence are 17 different study dates in which an individual mdr report will be submitted for each associated study date and medical record number/s (mrn) identified.
Patient Sequence No: 1, Text Type: D, B5
[20571327]
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 customizations has revealed that this specific change had the potential to introduce clinical inaccuracies in patient reports. Specifically: the original sentence of "there is mild prolapse of the tricuspid valve leaflets" has been changed to "there is bowing of the posterior leaflet of the tricuspid valve but no evidence of frank prolapse. " in this issue, the original sentence indicates presence of mild prolapse. The changed sentence describes the absence of prolapse and states that the posterior leaflet is bowing only. This has a different clinical meaning and could lead to overestimation of disease. Potential impact: if the change was made after reports had been generated with the original sentence selected, those reports prior to the change could display incorrect clinical data if viewed in rm or if used as a template for a repeat study on that patient. There has been no reported patient harm for this occurrence. 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. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1225058-2014-15636 |
MDR Report Key | 4660887 |
Report Source | 07 |
Date Received | 2014-12-12 |
Date of Report | 2014-12-12 |
Date of Event | 2014-11-13 |
Device Manufacturer Date | 2002-03-01 |
Date Added to Maude | 2015-05-19 |
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 | 2014-12-12 |
Model Number | IMPAX CV 2.08 |
Catalog Number | NA |
Lot Number | NA |
ID Number | NA |
Device Availability | Y |
Device Age | DA |
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 | 2014-12-12 |