[120707308]
The customer at (b)(6) reported on (b)(6) 2018 multiple invalids on the tigris platform, sn (b)(4). Product applications specialist (pas) review of the logs showed a delay in auto detect (ad) injection. There were seven samples potentially impacted due to (b)(6) results. Hologic advised the operator that they could report valid results; potential for (b)(6) results had not been communicated to the customer. On 09/01/2018, hologic communicated with the customer asking them to repeat the samples in questions and make necessary corrections to already reported results. The customer repeated testing on (b)(6) 2018 and made the necessary corrections to already reported results. Logs from (b)(6) 2018 were requested for further review. Per risk assessment, as a result of the ad injection delay, two ac2 and one (b)(6) assays failed. In addition, the ad injection delay likely resulted in (b)(6) results in the aptima (b)(6) assay which were likely reported to the respective physicians. However, hologic requested the customer to retest the samples in question, which was performed by the customer. Retesting samples is a customer inconvenience. If the (b)(6) result was obtained during repeat co-testing, a colposcopy is recommended. A colposcopy is an invasive procedure that allows the health care provider to look at the cervix through a magnifying device; a biopsy may be performed if the health care provider sees abnormal areas. It is an inconvenience for a patient to have a colposcopy performed for a cytology (b)(6) result. The severity associated with a (b)(6) result using the aptima (b)(6) assay is serious. To mitigate this risk, hologic requested the customer to retest the samples in question; the customer retested the samples and made the necessary corrected reports. Therefore, the probability of the patient having the incorrect aptima (b)(6) assay results is remote. The final risk is as far as possible. Further investigation into this issue is ongoing.
Patient Sequence No: 1, Text Type: D, B5