MAUDE Adverse Event Report: DIASORIN MOLECULAR LLC SIMPLEXA HSV 1 & 2 DIRECT KIT

Catalog Number	MOL2150
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/04/2026
Type of Reportable Event	Death
Event or Problem Description
Diasorin molecular received a complaint by phone on (b)(6) 2026 on the simplexa hsv 1&2 direct assay mol2150 lot 23498n for a suspected false negative hsv result while running an infant blood sample.The customer stated the first test was run on (b)(6) 2026 and resulted hsv negative for both hsv-1 and hsv-2.Based on the negative hsv result, the patient was treated with acyclovir starting on (b)(6) 2026 and discontinued the treatment on (b)(6) 2026.A new blood sample was obtained and run on (b)(6) 2026 on a different lot of mol2150 (lot 23863n) and resulted hsv-2 positive.Acyclovir treatment was restarted on (b)(6) 2026 at 17:47, but the patient is deceased as of (b)(6) 2026 at 20:54.
Additional Manufacturer Narrative
Diasorin molecular received a complaint by phone on (b)(6) 2026 on the simplexa hsv 1&2 direct assay mol2150 lot 23498n for a suspected false negative hsv result while running an infant blood sample.Runs were provided from the customer on (b)(6) 2026 with the results from (b)(6) 2026 and (b)(6) 2026 for anlaysis: run (b)(6) 2026 at 1414 (mol2150 lot 23498n, reaction mix lot 23497n): 6 unknown patient samples were run along with 1 positive control (mol2161 lot 23358n) and 1 "hsv neg" sample.All 6 unknown patient samples were not detected for hsv.Positive control was detected for both hsv-1 and hsv-2 targets."hsv neg" sample passed with no detection of hsv.All internal controls were detected and valid.It was not communicated which one of the 6 samples was the infant patient sample with the suspected false negative.Run (b)(6) 2026 at 1327 (mol2150 lot 23863n, reaction mix lot 23862n): 2 unknown patient samples noted as "whole blood" and 3 unknown patient samples noted as "csf" were run along with 1 positive control (mol2161 lot 23454n) and 1 "csf neg qc".Only one "whole blood" sample (id (b)(6)) resulted in hsv-2 detected.All other unknown patient samples were not detected for hsv.Positive control was detected for both hsv-1 and hsv-2 targets."csf neg qc" sample passed with no detection of hsv.All internal controls were detected and valid.Manufacturing record review showed the critical component, reaction mix mol2151 lot# 23497n, met all qc release criteria prior to kit release.Mol2151 lot# 23497n was tested using hsv-1 and hsv-2 positive controls and no-template controls (ntc).Positive controls were tested in quadruplicate at a 1:2000 dilution and once at 1:200 dilution with zero (0) occurrences of false negatives in either hsv-1 or hsv-2 targets.No malfunctions occurred during qc release testing.No trends were identified in the performance of the assay in either hsv-1 or hsv-2 targets during qc release.No trends were identified in the analysis of the raw material scorpion and reverse primers used in the manufacturing of several lots of mol2151 prior to and following the complaint lot 23497n.No abnormalities were detected during the production process.Retains of the suspected device mol2150 lot 23498n and the comparator lot mol2150 lot 23863m were tested on (b)(6) 2026 with 14 replicates (2 discs of 7 pc each) of mol2160 positive control.In both lots, the hsv targets were detected on all replicates.No false negatives occurred.No malfunctions occurred.Potential causes for the false negative results may be an operator error, incorrect handling of reagents during testing or storage, or deviation from the assay procedure outlined in the package insert.The customer's device and suspected false negative sample was not provided for investigation.It is not confirmed to be an assay reagent issue at this time.The customer is using whole blood as a sample type which is considered off-label.As stated in the instructions for use, ifuk.Us.Mol2150 rev 05, "the assay is not intended for use as a screening test for the presence of hsv-1 and hsv-2 in blood or blood products." and per the limitations section "negative results do not preclude hsv-1 or hsv-2 infection and should not be used as the sole basis for treatment or other patient management decisions.".

• Brand Name: SIMPLEXA HSV 1 & 2 DIRECT KIT
• Common Device Name: SIMPLEXA HSV 1 & 2 DIRECT KIT
• 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: 25257310
• Report Number: 2023365-2026-00001
• Device Sequence Number: 10541502
• Product Code: PGH
• UDI-Device Identifier: 20816101025507
• UDI-Public: (01)20816101025507(01)-(10)23498N-(17)2027-10-31
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K173798
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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 Catalogue Number: MOL2150
• Device Lot Number: 23498N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 26 DA
• Patient Sex: Male
• Patient Weight: 1 KG