MAUDE Adverse Event Report: HERPESELECT ELISA; NONE

Device Problem False Positive Result (1227)

Patient Problem No Information (3190)

Event Date 11/29/2013

Event Type  malfunction  

Event Description

I requested an std panel from (b)(4), who used (b)(4) to perform the (b)(6) test.I unexpectedly received a positive result for (b)(6), despite being zero-risk and totally asymptomatic.On researching extensively, i discovered that this test has a false rate of 50% for results less than 3.5.(my result was (b)(6), with normal being (b)(6).) this test should not be on the market.Reason for use: to rule out (b)(6), something this test does not do.

• Brand Name: HERPESELECT ELISA
• Type of Device: NONE
• MDR Report Key: 3603233
• MDR Text Key: 4070508
• Report Number: MW5034113
• Device Sequence Number: 1
• Product Code: LGC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 80