Agfa submitted mdr report 1225058-2010-00001 to the fda on 06/07/2010 for a site in the u.S.A (b)(6) 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.
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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: units changed in finding label that do not match the clinical concept.The original measurement definitions unit "bpm," has been changed to "beats/sec." the calculation that includes the heart rate typically requires the units to be in "bpm." it should be determined if there are any affected reports in the production system with this incorrect heart rate label.If reports are identified then, then the actual value displayed needs to be confirmed as the correct beats per minute value, as well as confirmation that any associated formula calculation(s) are correct, as it may or may not pull in the measurement label.If the value and calculations are correct, the associated hazard would be an ambiguous measurement.It should be noted that even if the values are correct, a user could become confused by the incorrect measurement label, and the label should be corrected as a quality issue.If the measurement value and/or calculations are incorrect, then the severity of the hazard becomes reportable.Potential impact: there is no potential impact reported at this time.As soon as agfa is made aware of any affected reports related to this specific finding, follow-up mdrs will be submitted for each associated study date and respective medical record number/s (mrn) identified.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.
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