Customer in (b)(6) reported their thinprep 5000 processor with autoloader printed a wrong vial id onto a slide.The instrument did not present any error to the operator.The customer sent pictures to (b)(4) for investigation and it was noted that the customer is using 1d barcodes on both slide and vial.It was confirmed that the sample was reprocessed without error on the same t5 autoloader.No patient recall or diagnosis delay noted.Fse confirmed but unable to reproduce error.Found the following to be the most likely cause of the error.Barcode scanner, scanner upgraded as part of (b)(4), documented on (b)(4).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.
|