MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HSV-2 IGG IMMUNOASSAY; HERPES SIMPLEX VIRUS SEROLOGICAL ASSAYS

Catalog Number 05572193160

Device Problem Low Test Results (2458)

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

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer complained of a questionable result for 1 patient tested for elecsys hsv-2 igg immunoassay (hsv-2 igg) on a cobas e 411 immunoassay analyzer with a serial number of (b)(4).In (b)(6) 2017 the patient tested (b)(6) for (b)(6) using polymerase chain reaction (pcr) testing.No further specific details were provided.On (b)(6) 2017 the patient had and (b)(6) result of (b)(6) that was tested on an e411 analyzer.On (b)(6) 2017 the same sample was tested for (b)(6) on a serion elisa with a result of (b)(6).The erroneous result was reported outside of the laboratory.There was no allegation of adverse event.Qc results were acceptable.The sample is not available for further investigation and a new sample (re-draw) from the patient is not possible.Without a sample available to investigate a root cause could not be determined.Discrepancies in results may occur in a given specimen, as determined by assays from different manufactures that may vary due to differences in reagent and assay methods.

• Brand Name: ELECSYS HSV-2 IGG IMMUNOASSAY
• Type of Device: HERPES SIMPLEX VIRUS SEROLOGICAL ASSAYS
• 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: 7024790
• MDR Text Key: 93217505
• Report Number: 1823260-2017-02594
• Device Sequence Number: 1
• Product Code: JJX
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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: Health Professional
• Type of Report: Initial
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 05572193160
• Device Lot Number: 193868
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• 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