MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IGG ANTIBODIES TO HERPES SIMPLEX VIRUS TYPE 2; ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2

Catalog Number 05572193160

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient when tested for (b)(6).It is not known if erroneous results were reported outside of the laboratory.This medwatch will cover (b)(6).Refer to medwatch with patient identifier (b)(6) for information on the (b)(6) erroneous results.The (b)(6) results were "repeatedly (b)(6)" on the e601 analyzer.The actual results were not provided.A serum sample was tested on a siemens bepiii system and the result was 24.6 ((b)(6)).No adverse event occurred.The e601 analyzer serial number was (b)(4).

Manufacturer Narrative

It was noted that no medical decisions were made based on the hsv-2 igg results.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.

Manufacturer Narrative

It was clarified that during the original incident, both a serum sample and a csf sample were tested on a siemens bepiii system and a ratio result was issued.This ratio results is then assessed according to a specified cut off.The results were 24.6 (positive).Patient sample is not available for investigation and no additional information is available for further investigation.

• Brand Name: IGG ANTIBODIES TO HERPES SIMPLEX VIRUS TYPE 2
• Type of Device: ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5629960
• MDR Text Key: 44510353
• Report Number: 1823260-2016-00580
• Device Sequence Number: 1
• Product Code: JJX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05572193160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR