MAUDE Adverse Event Report: BIOKIT, SA BIOKIT HSV-2 RAPID TEST; ENZYME LINKED IMMUNOABSORBENT ASSAY, HERPES SIMPLEX VIRUS, NON-SPECIFIC

Model Number 3000 28001

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

Twenty-one blood samples that were (b)(6) for (b)(6) on the diasorin liaison hsv test were submitted to (b)(6) for bio kit test.Six of the samples were biokit (b)(6): the 6 biokit (b)(6) samples were sent for western blot test 4 were wb (b)(6) for (b)(6).I was wb (b)(6) for (b)(6) was wb indeterminate for (b)(6).(b)(6) rate for biokit compared to western blot (run at university of (b)(6)) was 66%.The 6 biokit samples were run at (b)(6).Diasorin liaison is an fda-cleared screening test for (b)(6) by immunoassay.Western blot is the gold standard for confirmation and was run at the university of (b)(6) urology lab.

• Brand Name: BIOKIT HSV-2 RAPID TEST
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, HERPES SIMPLEX VIRUS, NON-SPECIFIC
• Manufacturer (Section D): BIOKIT, SA
• MDR Report Key: 9693750
• MDR Text Key: 179382414
• Report Number: MW5092892
• Device Sequence Number: 1
• Product Code: LGC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 3000 28001
• Device Lot Number: B31915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1