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 01/02/2023

Event Type  malfunction  

Manufacturer Narrative

Hologic technical support (ts) advised customer to perform a full monthly maintenance and clean the sample and reagent preparation areas.Ts reviewed logs and found no evidence of contamination based on the rlus and kinetic profiles of the results.There were no hardware failures which could have contributed to questionable results.Customer understood and agreed with the log review.Ts advised customer to recollect patient samples in the future if they are uncertain of the validity of the results.Customer performed monthly maintenance and monitored for further issues, but instrument was operational.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 they suspected contamination in one sars-cov-2 tma run using assay lot: 329277 on panther plus instrument sn: (b)(4).The worklist in question, (b)(4), had (b)(4) positives out of (b)(4) samples, as well as (b)(4) low positive samples (b)(6).The samples were not retested, but customer requested a log review from hologic technical support to confirm if the sample results were valid.The information provided by the customer was insufficient to characterize any sample as a confirmed false result.Results were not reported to patients.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: 16117386
• MDR Text Key: 308644134
• Report Number: 2024800-2023-00003
• 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
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PRD-06419
• Device Lot Number: 329277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2023
• 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