[49300830]
A customer in (b)(6) first reported an incident in (b)(6) 2016 to (b)(6) field service engineer (fse) where their thinprep 5000 processor with autoloader etched a slide with a wrong id number. *due to a misunderstanding of the event between the customer and (b)(6) field service engineer (fse), initially the incident was not considered a reportable event by the fse. The fse understood the event as the instrument could not read a slide id of one particular slide. The customer actually reported that the autoloader etched a slide with a wrong id number. The misunderstanding was discovered on (b)(6) when the customer reviewed the field service report from the fse visit in (b)(6) and noticed the miscommunication of the event, then notified hologic customer service and this event was elevated as a pae. Hologic's field service engineer (fse) confirmed with the customer that the patients sample was found and reprocessed. The barcode produced was correct and matched the vial id upon processing the sample the second time. Therefore, no patient recall was necessary. In addition, it was confirmed by the fse that no error code was presented to the operator. Fse confirmed but unable to reproduce the error, one slide printed with wrong id. Fse found the following to be the most likely cause of the error: vial barcode reader. Performed tsb 00882 to resolve the problem (see sr #(b)(4)). Ran go no-go test to verify instrument operation. Processed samples to confirm operation. Instrument operational. Although no patients needed to be recalled as a result of this incident this is a reportable event since the instrument did not perform as intended.
Patient Sequence No: 1, Text Type: D, B5