MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CMV IGG; 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	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys cmv igg assay on a cobas 8000 e 801 module (serial number (b)(4)).The sample resulted in a cmv igg value of 0.31 u/ml (non-reactive) when tested on the e 801 analyzer.The value from the e 801 analyzer was reported outside of the laboratory.An aliquot of this sample was sent to another laboratory for testing using the diasorin liaison xl method, resulting in a value of 104 u/ml (immune/reactive).
Additional Manufacturer Narrative
Samples from the patient were provided for investigation and the results obtained by the customer could be reproduced.
Additional Manufacturer Narrative
For calibrations performed on (b)(6)2022 and (b)(6)2022, signals were within expected ranges.On (b)(6)2022, controls recovered within specified ranges.Further investigations of the patient sample determined it to be correctly non-reactive with the elecsys cmv igg assay.The non-reactive elecsys cmv igg result was supported by mikrogen recomline blot results, which were negative for cmv igg and reactive for cmv igm.Further investigation indicated that a primary infection was unlikely due to the constant igm response and the absence of a seroconversion.

• Brand Name: ELECSYS CMV IGG
• 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: 14694060
• Report Number: 1823260-2022-01738
• Device Sequence Number: 6608746
• 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
• Serviced by Third Party (Y/N): Unknown
• 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): 08/19/2022

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 Expiration Date: 03/31/2023
• Device Catalogue Number: 07027117190
• Device Lot Number: 59618801
• 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: 05/23/2022
• Supplement Date Received by Manufacturer: 06/10/2022; 07/26/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 06/30/2022; 08/19/2022
• 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 Age: 26 YR
• Patient Sex: Female