[119866004]
On (b)(6) 2018, the customer at labcorp's (b)(4) site reported ((b)(4)) three (3) failed runs on their tigris instrument, sn (b)(4). Technical service (ts) reviewed tigris logs and found two (2) aptima combo 2 (ac2) runs and 1 aptima trichomonas vaginalis (atv) run that had failed due to auto detect (ad) injection delays. Hologic recommended the customer replace auto detect bottle caps. The customer called in again on the 8-20-18 (00367099) reporting additional run failures on ac2 and atv. A field service engineer was requested to go into the laboratory and service the instrument. To further assess the issue, a hologic product applications specialist (pas) reviewed tigris logs (sn (b)(4)) from 08/07/2018 - 08/20/2018 for all assay run on that tigris system. From that review, it was determined that a subset of samples from the customer's aptima hpv assay runs may have also been affected by the auto detect delay in injection. Hologic notified the customer and advised the customer to retest the samples. On 9-4-2018, hologic field application specialist (fas) spoke with the hpv manager at the (b)(4) laboratory who confirmed that the laboratory re-ran the samples and the corrected results were sent to physicians. There were no incorrect results associated with ac2 or atv samples, as these assays were invalidated due to errors caused by the injection delay. However, the ad injection delay likely resulted in false positive results in the aptima hpv assay which were reported to the respective physicians. The severity associated with a false positive result using the aptima hpv 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. Hologic sent in a field service engineer to confirm the instrument is performing as expected and that there were no further injection delay issues. Further investigation into this issue is ongoing.
Patient Sequence No: 1, Text Type: D, B5