MAUDE Adverse Event Report: HOLOGIC INCORPORATED APTIMA SARS-COV-2/FLU MULTIPLEX ASSAY

Catalog Number PRD-06815

Device Problem Erratic Results (4059)

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

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

Hologic product application specialist (pas) review of the logs and did not find any reagent preparation issues or hardware issues.Of note, sample result produced rlu's between 565k - 738k, which is lower than what is typically seen in positive samples.Thus, per pas analysis, the sample may be low target sample, which may not repeat upon retesting, or the samples may possibly be contaminated.

Event Description

Customer reported that they obtained incorrect results for third party external quality control samples (eqcs) during aptima sars-cov-2/flu assay validation.In addition, the customer noted that a sample from worklist (b)(4) that previously produced positive result using the aptima sars-cov-2 assay lot 306139, produced negative sars-cov-2 result during aptima sars-cov-2/flu assay validation using lot 303906.

Manufacturer Narrative

2024800-2021-00077 initial report incorrectly coded against product code qjr lot 306139.The correct assay in question is product code qlt lot 303906.- updated information from brand name to aptima sars-cov-2/flu multiplex assay.- updated common device to covid-19 multi-analyte respiratory panel nucleic acid devices.- updated product code to qlt.- updated catalog # prd-06815.- updated lot# 303906.- updated unique indentifier (udi) # to (b)(4).

• Brand Name: APTIMA SARS-COV-2/FLU MULTIPLEX ASSAY
• Type of Device: SARS-COV-2/FLU MULTIPLEX ASSAY
• Manufacturer (Section D): HOLOGIC INCORPORATED; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC INCORPORATED; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: abel saluta ; 10210 genetic center drive; san diego, CA 92121 ; 8584108506
• MDR Report Key: 13078268
• MDR Text Key: 282805994
• Report Number: 2024800-2021-00077
• Device Sequence Number: 1
• Product Code: QLT
• 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,Followup
• Report Date: 12/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PRD-06815
• Device Lot Number: 303906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1