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	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received a questionable result for one patient sample tested with the elecsys cmv igg assay on a cobas 8000 e 801 module.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.The sample resulted in a (b)(6) igg value of (b)(6) coi ((b)(6) accompanied by a data flag.The sample was tested on an abbott architect analyzer, resulting in a (b)(6) igg value that was 16 times the cutoff value.The reporter stated that (b)(6) infection of the patient is compatible with the patient's clinical picture.The serial number of the e801 analyzer is (b)(4).
Additional Manufacturer Narrative
A sample from the patient was provided for investigation and the results obtained by the customer could be reproduced.The investigation is ongoing.
Additional Manufacturer Narrative
The customer stated that a second sample from the same patient was collected 6 days after collection of the complained sample.Both cmv igg and cmv igg tests were reactive for this sample.Cmv igg calibration data from 25-oct-2021 was within specifications.The provided quality control data showed recoveries that were mostly within specified ranges.The investigation determined the complained sample is non-reactive in the elecsys cmv igg assay.The result was discrepant to results obtained with the recomline cmv igg assay, which showed a clearly reactive result.The close-to-cut-off reactivity in the elecsys cmv igm assay suggests the presence of low levels of early cmv specific immunoglobulins.Considering the clinical picture of the patient, the issue is consistent with a presumed early phase of cmv infection of the patient.The lack of reactivity in the elecsys cmv igg assay might result from the absence of the p65 antigen in the assay.According to recomline results, the major driver of reactivity in this sample is the p65 antigen, which is not contained in the elecsys cmv igg assay.The investigation could not identify a product problem.Per product labeling, single false negative results can occur.The reagent performs within specifications.

• 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: 12860026
• Report Number: 1823260-2021-03447
• Device Sequence Number: 11930107
• Product Code: LFZ
• UDI-Device Identifier: 04015630940172
• UDI-Public: 04015630940172
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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
• Report Date (Section B): 02/04/2022

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: 522583
• 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: 11/03/2021
• Supplement Date Received by Manufacturer: 11/30/2021; 01/14/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/16/2021; 02/04/2022
• 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: Unknown