MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA SARS COV-2; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Catalog Number PRD-06419

Device Problem Device Contaminated at the User Facility (4064)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

Hologic field service engineer (fse) went onsite four separate times to service the affected instrument.First, fse performed monthly maintenance and cleaned the entire instrument using bleach and water, paying particular attention to the sample mix/load stations and tip chute.Second, fse replaced the amplification incubator and all rtf modules.Third, fse checked the luminometer for solid buildup and ran monthly maintenance.Fourth, fse replaced the chiller unit and performed another internal cleaning.After each visit, fse would run 40 negative or blank tubes, but one or two tubes would result positive, indicating the contamination was still present.This is a preliminary report as investigation is ongoing.Supplemental reports will be submitted as necessary.As part of eua agreement, fda requires all aptima sars-cov-2 assay questioning results and false results (confirmed or not) complaints to be reported as malfunction mdr.

Event Description

Hologic molecular applications specialist (mas) reported on behalf of customer that there was potential contamination in their sars-cov-2 tma runs using assay lot 318311 on panther instrument sn (b)(4).Customer questioned if there were false positive results after noticing a higher positivity rate compared to their other panthers, as well as observing negative samples with rlu values in the 500s (sample ids and worklists not provided).After noticing this trend, customer began running their sars-cov-2 samples on other panthers located in a different room than the affected instrument.Hologic field service engineer (fse) went onsite four separate times to clean the instrument, perform monthly maintenance, and replace any defective modules.After each visit, fse would run 40 negatives/empty lyse tubes, but one or two samples would still result positive.The information provided by the customer was insufficient to characterize any sample as a confirmed false result.There was no indication of results being reported or any treatment given to patients.This is a preliminary report as investigation is ongoing.Supplemental reports will be submitted as necessary.

Manufacturer Narrative

H3 other text : other.

Event Description

After submission of the initial mdr on 08/23/2022, further investigation of this event was performed.Consultation with field service engineer revealed additional information.As a result, this report is being submitted as a conclusion of the previous report.

Event Description

Follow-up report.See section h10.

Manufacturer Narrative

The following is a resubmission that was initially submitted as a follow up mdr (2024800-2022-01084) on 08/25/2022 by hologic.After submission of the initial mdr on 08/23/2022, further investigation of this event was performed.Consultation with field service engineer revealed additional information.As a result, this report is being submitted as a conclusion of the previous report.Hologic molecular applications specialist (mas) reported on behalf of customer that there was potential contamination in their sars-cov-2 tma runs using assay lot 318311 on panther instrument sn (b)(6).Customer questioned if there were false positive results after noticing a higher positivity rate compared to their other panthers, as well as observing negative samples with rlu values in the 500s (sample ids and worklists not provided).After noticing this trend, customer began running their sars-cov-2 samples on other panthers located in a different room than the affected instrument as of (b)(6) 2022.Fse later confirmed on (b)(6) 2022 that no patients received treatments due to incorrect test results.Hologic field service engineer (fse) went onsite four separate times to service the affected instrument.On (b)(6) 2022, fse performed monthly maintenance and cleaned the entire instrument using bleach and water, paying particular attention to the sample mix/load stations and tip chute.Second, fse replaced the amplification incubator and all rtf modules.Third, fse checked the luminometer for solid buildup and ran monthly maintenance.Fourth, fse replaced the chiller unit and performed another internal cleaning.After each visit, fse would run 40 negative or blank tubes, but one or two tubes would result positive, indicating the contamination was still present.Mas and fse returned a final time and ran swabs from (b)(4) different modules in the affected instrument.The following areas had swabs with positive results (rlu > 600) and deemed contamination zones: magnetic parking stations 1 and 2, magnetic wash station 2, luminometer, mtu input queue, transition incubator, and the universal fluids drawer.Fse decontaminated the instrument and room a final time, then ran (b)(4) blank tubes which all came back negative.No further actions required from hologic.As part of eua agreement, fda requires all aptima sars-cov-2 assay questioning results and false results (confirmed or not) complaints to be reported as malfunction mdr.

Event Description

See section h11.

Manufacturer Narrative

Section b5 stated "follow-up report.See section h10." when it should have referenced section h11.

• Brand Name: APTIMA SARS COV-2
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: kyleigh jacobs ; 10210 genetic center drive; san diego, CA 92121 ; 8584108566
• MDR Report Key: 15275225
• MDR Text Key: 301828370
• Report Number: 2024800-2022-01084
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PRD-06419
• Device Lot Number: 318311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 07/26/2022; Not provided; Not provided
• Supplement Dates FDA Received: 08/25/2022; 07/17/2024; 07/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1