MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HSV-1 IGG IMMUNOASSAY; HERPES SIMPLEX VIRUS, HSV-1

Model Number HSV-1

Device Problem Low Test Results (2458)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

The investigations for the 1 event did not identify a product problem.The cause of the event could not be determined.Non-reactive test results do not completely rule out the possibility of hsv-1 infection.Individuals may not exhibit any detectable igg antibodies at an early stage of acute infection.False negative results may occur when the hs-virus is glycoprotein g (gg) deficient.The follow up/corrective actions for the 1 event was as follows: the patient sample was requested for investigation but could not be provided.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.An erroneous low result was generated by the cobas e 411 immunoassay analyzer.The events involved a total of 1 patient with the following: a low elecsys hsv-1 igg immunoassay (hsv-1 igg) result.

Manufacturer Narrative

The sample was requested for investigation but could not be provided.Calibration and qc were acceptable.The cause of the event could not be determined.Non-reactive test results do not completely rule out the possibility of hsv-1 infection.Individuals may not exhibit any detectable igg antibodies at an early stage of acute infection.False negative results may occur when the hs-virus is glycoprotein g (gg) deficient.

Event Description

The initial report was inadvertently filed as a voluntary manufacturer summary report.This supplemental is to update missing information.The initial reporter complained of a false negative result for 1 patient sample tested for elecsys hsv-1 igg immunoassay (hsv-1 igg) on a cobas e 411 immunoassay analyzer.The initial result from the e411 analyzer was 0.072 coi (negative).The repeat from the e411 analyzer was 0.070 coi (negative).On (b)(6) 2019 the repeat from the e411 analyzer was 0.085 (negative).The sample was tested by the liaison diasorin method with a "negative" result.The actual result was not provided.The sample was tested by the immulite and ecolab methods and the results were "positive." the actual results were not provided.The patient claimed to be hsv positive and had been receiving treatment in another medical facility for "some time." further details about the medication and specific time frames were not available.The e411 analyzer serial number was (b)(4).

• Brand Name: ELECSYS HSV-1 IGG IMMUNOASSAY
• Type of Device: HERPES SIMPLEX VIRUS, HSV-1
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8549742
• MDR Text Key: 143413945
• Report Number: 1823260-2019-90090
• Device Sequence Number: 1
• Product Code: MXJ
• Combination Product (y/n): N
• PMA/PMN Number: K120625
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2019
• Device Model Number: HSV-1
• Device Catalogue Number: 05572185190
• Device Lot Number: 30828200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1