MAUDE Adverse Event Report: HOLOGIC, INC APTIMA HPV SCREENING ASSAY; IN-VITRO DIAGNOSTIC

Catalog Number	303069
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Final investigation results: hologic performed an investigation to determine the root cause for the potential false positive hpv results using the aptima hpv assay.Briefly, the investigation concluded that the potential false positive hpv results were caused by air bubbles that entered the auto detect injection line prior to when the tigris processed the first sample of an mtu.The aptima hpv assay produces two different rlu signal types: 1) the internal control-specific amplicon, which is detected using a probe with a rapid emission of light (flasher) and 2) the hpv specific amplicon, which is detected using probes with relatively slower kinetics of light emission (glower).An air bubble would delay the auto detect reagents from reaching the sample tube when the instrument luminometer initiates rlu reads.This delay in rlu response shifted the internal control-specific flasher signal to appear in the glower signal range, potentially producing a low positive hpv result.Generally, air bubbles in the lines are apparent based on the calibrators and controls invalidating assay runs.Therefore, if a customer contacts hologic, the risk of reporting potential false positive hpv results by that particular customer may be mitigated.A field service engineer was sent to the site and either cleaned or replaced the auto detect 2 syringe, which eliminated the air bubble forming in the injection lines.Per risk assessment, 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 additionally, the frequency of an air bubble causing incorrect results is remote occurrence.
Event or Problem Description
This is the final report for 2024800-2018-00008 with investigation results.

• Brand Name: APTIMA HPV SCREENING ASSAY
• Common Device Name: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): HOLOGIC, INC; 10210 genetic center dr; san diego CA 92121
• MDR Report Key: 7864644
• Report Number: 2024800-2018-00008
• Device Sequence Number: 1911516
• Product Code: OYB
• UDI-Device Identifier: 15420045500051
• UDI-Public: 15420045500051
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: 303069
• Device Lot Number: 239642, 240090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other