[122312011]
On (b)(6) 2018, customer, (b)(6), at (b)(6) contacted technical support (ts) regarding an increase in number of (b)(6) results. Results from these assays were reported to physicians between (b)(6) 2018. Hologic product application specialist (pas) reviewed the logs and confirmed the increase in (b)(6) results. The customer acknowledged that they incorrectly installed sample shield which led to the contamination seen in the results. Pas noted that there were several (b)(6) across three runs. Since there was a high prevalence of (b)(6) results for both the (b)(4) assays in the three assay runs, the initial run results should have been considered suspect. The customer acknowledged that the results should not have been released. Per risk assessment, if the patient received a (b)(6), the cdc recommended treatment for the patient is antibiotics including (but not limited to) azithromycin or doxycycline for (b)(6), ceftriaxone and azithromycin for (b)(6), and metronidazole or tinidazole for (b)(6). If the patient is pregnant, the physician is expected to ensure that the appropriate, safe antibiotic is administered to the patient based on the nature of the infection. The potential impact to the patient is inconvenience, anxiety, and unnecessary antibiotic use. The risk of reporting an incorrect std diagnostic result is considered "serious. " the customer reran the samples from the initial three assay runs on a different instrument to resolve the issue. Customer indicated that the re-run results were within the expected (b)(6) rate of the lab but did not provide hologic the number of incorrect samples that were initially sent to physicians. The corrected results were sent to physicians on 09/21/2018. Hologic will work with customer to provide training to cpl operators on proper sample shield replacement. Further investigation into this issue is ongoing.
Patient Sequence No: 1, Text Type: D, B5