MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CMV IGG ASSAY; ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Catalog Number	07027117190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was requested for investigation.
Event or Problem Description
The initial reporter received (b)(6) elecsys cmv igg results for one patient sample with the cobas e 801 module serial number (b)(4).On (b)(6) 2021, the patient¿s elecsys result was (b)(6).On (b)(6) 2021, the patient¿s elecsys result on a second sample was (b)(6).On (b)(6) 2021, the patient¿s elecsys result on a third sample was (b)(6).Repetition using the elecsys, the sample was (b)(6).Repetition using a vidas analyzer at the customer¿s site, the sample was (b)(6).In another laboratory with an unknown method, the sample was (b)(6).The (b)(6) result was reported to the patient.It is unknown which of the samples was tested in the other laboratory or used for repetition testing.
Additional Manufacturer Narrative
Discrepant results for a fourth sample drawn from the patient performed on (b)(6)-2021 are as follows: the elecsys result was 0.313 u/ml (negative).The vidas result was 11 ua/ml (positive).Medwatch field b6 has been updated.
Additional Manufacturer Narrative
Two samples from the patient drawn on (b)(6) 2021 were submitted for investigation.One sample was tested with cmv igg reagent lot 481076 on a cobas e801 module: the cmv igg result was 0.292 u/ml (negative).The cmv igm result was 0.204 coi (negative).The customer's results were reproduced at the investigation site.The investigation is ongoing.
Additional Manufacturer Narrative
Upon additional investigation, the results of the customer's elecsys cmv igg assay and elecsys cmv igm assay could be confirmed.Application of an additional method from an independent third party (recomline cmv igg, mirkogen) showed reactive cmv igg results.The investigated sample was non-reactive in both the elecsys cmv igg and the elecsys cmv igm assay.Discrepancies to competitor cmv igg assays were observed, but no clear serologic picture for this patient could be generated.For safety reasons, the pregnant patient should be considered cmv seronegative to maintain cautious behavior.The elecsys cmv igg reagent performs within specification.

• Brand Name: ELECSYS CMV IGG ASSAY
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
• 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: 12447512
• Report Number: 1823260-2021-02650
• Device Sequence Number: 17465985
• Product Code: LFZ
• UDI-Device Identifier: 04015630940172
• UDI-Public: 04015630940172
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K131605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/14/2021

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: 07027117190
• Device Lot Number: 481076
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 09/13/2021; 09/29/2021; 11/24/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/04/2021; 10/22/2021; 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female