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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DIASORIN INC. LIAISON HSV-2 TYPE SPECIFIC IGG; ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2

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DIASORIN INC. LIAISON HSV-2 TYPE SPECIFIC IGG; ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2 Back to Search Results
Device Problem False Positive Result (1227)
Patient Problem Insufficient Information (4580)
Event Date 04/27/2023
Event Type  Injury  
Event Description
Patient had a hsv 2 positive test on the diasorin hsv 1 and 2 igg test, (index value = 1.14), followed up with a western blot which was negative for hsv 1 and 2.Date given is the western blot confirmatory test.
 
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Brand Name
LIAISON HSV-2 TYPE SPECIFIC IGG
Type of Device
ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2
Manufacturer (Section D)
DIASORIN INC.
MDR Report Key17229626
MDR Text Key318242420
Report NumberMW5118985
Device Sequence Number1
Product Code MYF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse Practitioner
Type of Report Initial
Report Date 06/26/2023
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? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/28/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age21 YR
Patient SexMale
Patient Weight73 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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