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

Catalog Number PRD-06419

Device Problem Erratic Results (4059)

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

Event Date 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

Hologic technical support (ts) reviewed logs and found no hardware or reagent preparation issues in the affected wl.Ts advised customer to clean the sample and reagent preparation areas and any touchpoints, discard any open kits, prepare a new one, and run 30 blanks on the panther and fusion sides of the instrument.Customer performed the recommended cleaning and ran blanks which all resulted negative.Hologic product applications specialist (pas) reviewed logs and noticed some borderline and low positive results with no apparent pattern.The kinetic curves and controls were normal, and there were no reagent preparation issues.Ts relayed the pas review to customer and recommended they continue to run and monitor as there were no reagent preparation issues found.Customer notified the collection sites to not touch the foil caps, change gloves, put one specimen per bag, and ensure the ice will not contact the samples if it melts.Customer continued to run without further issues.Pas noticed the thermocycler rfus were lower than expected for many wells, so a hologic field service engineer (fse) was dispatched to service the thermocycler.Fse attempted to clean the thermocycler wells, but the entire module was replaced instead.Instrument was operational and released back to customer.No further issues were reported.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

Customer reported one sars-cov-2 tma run using assay lot 320040 on panther fusion instrument sn (b)(4) which had a high positivity rate.The worklist in question, 003301-20221206-03, had 13 positives out of 27 samples.The affected reagent kit was used the next day and did not have an abnormal number of positive samples.The information provided by the customer was insufficient to characterize the sample as a confirmed false result.Results were reported to patients, but there was no mention of any patient treatment or impact.Customer did not repeat the positive samples as they discarded the specimens, nor did they amend any results.There were no associated/reported adverse events.

• 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: 16095606
• MDR Text Key: 308556118
• Report Number: 2024800-2023-00002
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2023

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: 320040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 01/04/2023
• 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