BEUDAMED
    FDA Adverse Event Death Summary report: Y

    SIMPLEXA HSV 1 & 2 DIRECT KIT

    MDR report key: 25257310 · Received May 22, 2026

    Report

    Report Number
    2023365-2026-00001
    Event Type
    Death
    Date Received
    May 22, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 22, 2026
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    PGH
    UDI-DI
    20816101025507
    PMA / PMN Number
    K173798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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."

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546296 SIMPLEXA HSV 1 & 2 DIRECT KIT SIMPLEXA HSV 1 & 2 DIRECT KIT PGH DIASORIN MOLECULAR LLC 23498N 20816101025507

    Patients

    Seq Age Sex Outcome Treatment
    1 26 DA Male Death