MAUDE Adverse Event Report: DIASORIN MOLECULAR LLC SIMPLEXA COVID-19 DIRECT ASSAY; REAL TIME RT-PCR ASSAY FOR THE IVD QUALITATIVE DETECTION OF SARS-COV-2 VIRAL RNA

Catalog Number	MOL4150
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Diasorin molecular llc received a complaint on (b)(6) 2024 alleging false positive results with the simplexa covid-19 direct assay with only 1 of 2 targets detected (no s-gene, but orf1ab detected).Upon repeat on a competitor assay (bd-max), the results were negative.Run analysis of the provided simplexa results are as follows: run on (b)(6) 2024 at 1205, sample id: (b)(6): s gene (not detected), orf1ab (33.0), rna ic (28.8), run on (b)(6) 2024 at 1629, sample id: (b)(6): s gene (not detected), orf1ab (31.7), rna ic (28.8), run on (b)(6) 2024 at 0926, sample id: (b)(6): s gene (not detected), orf1ab (27.4), rna ic (27.3), run on (b)(6) 2024 at 0802, sample id: (b)(6): s gene (not detected), orf1ab (25.7), rna ic (25.2), run on (b)(6) 2024 at 1058, sample id: (b)6): s gene (not detected), orf1ab (26.4), rna ic (25.4).Results from the bd-max assay were shared with sample id: (b)(6) showed no detection of the assay's cov2 target after melt curve analysis on (b)(6) 2024.It is not known which samples from the simplexa runs were run on the bd-max melt curve analysis assay.It was discovered the bd max targets the orf1a and includes additional internal controls (ms2 and beta-actin) for extraction and sample quality validation.The simplexa assay does not utilize extraction of the sample and only requires 1 of 2 targets (s gene or orf1ab) for a positive covid interpretation.The customer's samples were not available for testing.No recent runs were provided for analysis.Batch record review showed the critical component, reaction mix mol4151 lot#: x18871n, met all qc release criteria prior to kit release.Mol4151 lot#: x18871n was tested using positive controls and no-template controls (ntc).Positive controls were tested in quadruplicate and resulted in zero (0) occurrences of false negatives in any of the covid-19 targets.All positive controls were detected at an average ct = 26.4 (s gene), 26.4 (orf1ab), and the internal control avg ct = 30.6.No malfunctions occurred during qc release testing.Retains of the suspected device were previously tested on 01/09/2024 with 14 replicates (2 discs of 7 pc each) of mol4160 positive control.Both times the targets were detected on all replicates (s gene avg ct = 27.0 / orf1ab avg ct = 27.4).Ntc remained not detected when tested in duplicate.No malfunctions occurred.Potential causes for false positive results may be an instrument failure or error, an operator error, incorrect handling of reagents during testing or storage, or deviation from assay procedures outlined in the package insert.The customer's device and suspected false positive sample was not provided for investigation.It is not confirmed to be an assay reagent issue at this time.This is the 1st complaint on x18870n.The product expired on 09/30/2024 and is no longer available for additional investigation.
Event or Problem Description
Diasorin molecular llc received a complaint on (b)(6) 2024, alleging false positive results with the simplexa covid-19 direct assay with only 1 of 2 targets detected (no s-gene, but orf1ab detected).Upon repeat on a competitor assay (bd-max), the results were negative.The customer confirmed no alleged harm occurred.

• Brand Name: SIMPLEXA COVID-19 DIRECT ASSAY
• Common Device Name: REAL TIME RT-PCR ASSAY FOR THE IVD QUALITATIVE DETECTION OF SARS-COV-2 VIRAL RNA
• Manufacturer (Section D): DIASORIN MOLECULAR LLC; 11331 valley view street; cypress CA 90630
• Manufacturer (Section G): DIASORIN MOLECULAR LLC; 11331 valley view street; cypress CA 90630
• Manufacturer Contact: kwang kim ; 11331 valley view street; cypress, CA 90630 ; 5622406323
• MDR Report Key: 20679515
• Report Number: 2023365-2024-00005
• Device Sequence Number: 20653331
• Product Code: QJR
• UDI-Device Identifier: 20816101027020
• UDI-Public: (01)20816101027020(10)X18870N(17)2024-09-30
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: MOL4150
• Device Lot Number: X18870N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown