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 11/11/2022

Event Type  malfunction  

Event Description

Customer reported questioning a discrepant sars-cov-2 tma sample run on panther instrument (b)(4).The sample initially tested positive (731 rlus), but it was retested per the lab¿s protocol to retest any result between 500-1000 rlus.Customer took two new aliquots which both resulted negative (531 and 273 rlus), and customer questioned why the sample with 531 rlus was deemed negative since it surpassed the positive threshold.Customer mentioned the sample in question as part of a general inquiry on sample result interpretation and therefore did not send logs, worklist ids, sample ids, assay lot, etc.To hologic for review.The information provided by the customer was insufficient to characterize the sample as a confirmed false result.There were no indications of results reported, any associated/reported adverse events, or patient impact reported.

Manufacturer Narrative

Hologic technical support (ts) explained that rlus represent light from both ic signal (flasher) as well as analyte signal (glower); the instrument determines if the signal coming from the glower is enough to be called positive.Ts suggested the sample in question was likely a low target sample that would not repeat.Customer mentioned the sample in question as part of a general inquiry on sample result interpretation and therefore did not send logs, worklist ids, sample ids, assay lot, etc.To hologic for review.Hologic molecular application specialist went onsite and revisited the specifics of the sars-cov-2 tma package insert.Customer understood and reported no further issues.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.

• 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: 15849798
• MDR Text Key: 307624674
• Report Number: 2024800-2022-01108
• 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: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• 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: 11/10/2022
• 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