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 09/08/2022

Event Type  malfunction  

Event Description

Customer reported positive contamination on two of their panther instruments, panther fusion sn (b)(4) and panther sn (b)(4), during monthly environmental swab testing.Swabs which should have resulted negative had low positive results instead, indicative of instrument contamination.Customer stated their panther instruments were used for sars-cov-2 testing but did not specify which sars-cov-2 assay was used/affected at this time.Hologic contacted customer multiple times but could not reach them to obtain further information such as affected assay lots, worklists, or sample ids.The information provided by the customer was insufficient to characterize any sample as a confirmed false result.Hologic confirmed that customer did not report out positive results during the affected period without confirming their validity on another platform.There were no associated/reported adverse events or patient impact reported.

Manufacturer Narrative

Customer performed a deep-clean monthly maintenance, including sample shields, racks, reagent and sample preparation areas, but issue persisted.Customer performed a second decontamination, which resolved the issue and generated valid results.Hologic technical support and applications specialists attempted to obtain more information multiple times from customer, but they were unresponsive.No further investigation or troubleshooting could be completed, but 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.Device evaluated by mfr: other.

• 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: 15537394
• MDR Text Key: 301837969
• Report Number: 2024800-2022-01095
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PRD-06419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2022
• 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