MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-02-28 for IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08) IMPAX CV RM 2.08 manufactured by Agfa Healthcare Corp..
[4840036]
Agfa submitted mdr report# 1225058-2010-00001 to the fda on june 7, 2010 for a site in the us. A 7th occurrence is being reported for the same issue/same device: impax cv results management administration tool (rmat). The customer, the initial reporter, in this new event contacted agfa on february 14, 2014 and reported a reading physician had discovered an incorrect statement in the pulmonary artery findings within their rmat reporting. The customer confirmed there were no reports of patient harm during this event. The customer stated no rmat customization requests had been made to agfa, and the site's super user had not made any custom changes to the pulmonary artery findings within the reporting tool, abiding by agfa's rmat terms of use. The customer described when reports were created for trans esophageal echocardiogram (tee), transthoracic echocardiogram (tte) and stress (str) studies, and when the end-user selected the "mild to moderate" radio button in the pulmonary artery pathology section, the incorrect sentence finding of "there is mild to moderate pulmonary hypotension" was generated in the report. The sentence finding should read "there is mild to moderate pulmonary hypertension. " the same day the customer reported the event, agfa corrected the statement in both the test and production environments and; in turn, the customer reviewed the correction and confirmed the statement was reading correctly with "hypertension" versus "hypotension". Agfa confirmed rmat super user was disabled.
Patient Sequence No: 1, Text Type: D, B5
[12370029]
(b)(4). Eval summary: agfa is currently reviewing the rmat logs to identify when the customization change was introduced into the production environment. (b)(4). Agfa's clinical analyst also determined from a study selected from the potentially affected rmat log, that the incorrect sentence finding line was located directly above the actual measurements (which are correct) and that a user would be more likely to look at the actual measurements in a report to formulate conclusions and treatment decisions; an inclination as to why the reading physicians missed the incorrect sentence finding of "hypotension" versus "hypertension " in the many previous pulmonary artery pathology reports. A reportable correction is underway for this issue and has been reported to the fda. Fda reference# is z-2112-10. Any further investigation for the site described in this report will be documented in the ongoing cfr part 806 reporting.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1225058-2014-00128 |
| MDR Report Key | 4113156 |
| Report Source | 07 |
| Date Received | 2014-02-28 |
| Date of Report | 2014-02-14 |
| Date of Event | 2014-02-14 |
| Date Mfgr Received | 2014-02-14 |
| Device Manufacturer Date | 2010-02-01 |
| Date Added to Maude | 2014-10-01 |
| 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 Contact | MS. DEBBIE HUFF |
| Manufacturer Street | 10 SOUTH ACADEMY STREET |
| Manufacturer City | GREENVILLE SC 29601 |
| Manufacturer Country | US |
| Manufacturer Postal | 29601 |
| Manufacturer Phone | 8644211754 |
| Single Use | 3 |
| 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 | 2014-02-28 |
| Model Number | IMPAX CV RM 2.08 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-02-28 |