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

Catalog Number	ASKU
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem 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).
Additional 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.
Additional 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.
Additional 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
• Common Device Name: HERPES SIMPLEX VIRUS SEROLOGICAL ASSAYS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7906288
• Report Number: 1823260-2018-03284
• Device Sequence Number: 940577
• Product Code: MYF
• UDI-Device Identifier: 04015630939053
• UDI-Public: 04015630939053
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K121895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: 258198
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/04/2018; 09/04/2018; 09/04/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/01/2018; 11/05/2018; 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1