Catalog Number 200100-US |
Device Problem
Data Problem (3196)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Company technical support visited the site and was unable to replicate the issue.This incident is currently under investigation and a follow-up report will be filed.
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Event Description
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Customer reported that the rotem merged the demographic from one patient with the result of another patient on the report.The patient results were not used for treatment and no patient harm was reported.
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Manufacturer Narrative
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A capa was initiated as part of the investigation.Root cause is a defect in the software that allows a click by a user within a certain time window to alter the association of patient data from one sample to another.A new software was released, and confirmed with correction of the defect.New software changes the way data is presented by using a pdf viewer.This method prevents the actions from the user (inadvertent clicks) from altering the information presented and the association of that information within the record.The next step of the capa is reviewing complaints at the of july and ensuring that has not been a recurrence of the defect.
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Event Description
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Customer reported that the rotem merged the demographic from one patient with the result of another patient on the report.The patient results were not used for treatment and no patient harm was reported.
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Search Alerts/Recalls
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