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

Catalog Number ASKU

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer complained of (b)(6) results for 1 patient tested for elecsys hsv-1 igg immunoassay (hsv-1) and elecsys hsv-2 igg immunoassay (hsv-2) on a cobas 8000 e 602 module.This medwatch will cover (b)(6).Refer to medwatch with (b)(6) for information on the (b)(6) results.On (b)(6) 2018 the patient was "(b)(6)" by a polymerase chain reaction (pcr) test for (b)(6); the actual results were not provided.The same day the patient was tested by an immulite analyzer and the (b)(6) results were (b)(6).On (b)(6) 2018 a new sample was obtained and the patient had a "(b)(6)" pcr result for (b)(6); the actual results were not provided.The sample from (b)(6) 2018 was tested on the immulite analyzer and the (b)(6) results were (b)(6).The same sample was tested on the e602 module and the (b)(6) result was (b)(6) and the (b)(6) result was (b)(6).The laboratory took the sample from (b)(6) 2018 and ran additional tests for igm by the elisa method.The (b)(6) result was (b)(6) and the (b)(6) result was "(b)(6)" (actual result not provided).The (b)(6) test result from the vector-best method was (b)(6).The (b)(6) results from the e602 module were reported outside of the laboratory.There was no allegation that an adverse event occurred.There is an "(b)(6)" result of (b)(6) documented from (b)(6) 2018.This may be a result from the immulite method but this is not clear.It is not clear if this result is from a new sample or from the (b)(6) 2018 sample.Clarification on this has been requested but has not yet been provided.The customer was not having any calibration or qc issues.The e602 module serial number was (b)(4).

Manufacturer Narrative

The calibration and qc recoveries within specified ranges.The assay is performing within specification.The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

It was clarified that the hvg result of 17.6 coi with a date of 03-sep-2018 was a repeat of the 31-aug-2018 sample by the immulite method.

Manufacturer Narrative

The customer provided 3 samples from the patient for investigation.The investigation determined all samples were negative for hsv-2 igg and hsv-2 igg immunoblot results were negative for hsv.

• 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
• MDR Report Key: 7906288
• MDR Text Key: 124683258
• Report Number: 1823260-2018-03284
• Device Sequence Number: 1
• Product Code: MYF
• UDI-Device Identifier: 04015630939053
• UDI-Public: 04015630939053
• Combination Product (y/n): N
• PMA/PMN Number: K121895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: 258198
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 09/04/2018; 09/04/2018; 09/04/2018
• Supplement Dates FDA Received: 10/01/2018; 11/05/2018; 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1