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

Catalog Number	07027133190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas e 801 analytical unit is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for two patient samples tested with elecsys cmv igm on a cobas e 801 analytical unit in comparison to results measured with a competitor method.The first sample was tested with the competitor method on (b)(6) 2023, resulting in a cmv igm value of 1.51 index (reactive).The first sample resulted in a cmv igm value of 0.568 coi (non-reactive) when tested on the e 801 analyzer on (b)(6) 2023.The second sample was tested with the competitor method on (b)(6) 2023, resulting in a cmv igm value of 1.76 index (reactive).The first sample resulted in a cmv igm value of 0.221 coi (non-reactive) when tested on the e 801 analyzer on (b)(6) 2023.
Additional Manufacturer Narrative
The customer reported they received discrepant cmv igm results for a third patient sample.This third sample has a non-reactive cmv igm result when tested with the roche method and a reactive result when tested with the competitor method (abbott alinity).Calibration signals from 25-sep-2023 were within expected ranges.Quality controls measured on the day of the event were within range.The patient samples were provided for investigation.The first and third samples were determined to be non-reactive with the cmv igm assay and were no in accordance with reactive results from another manufacturer.Additional analyses showed that these samples contained cmv-specific igg antibodies of high avidity, suggesting other methods may detect persisting cmv igm antibodies in these samples.Overall, the results do not indicate an early phase of infection with cmv.For sample 2, the majority of methods delivered non-reactive cmv igm and igg results.The patient is considered seronegative for cmv.The investigation determined the cmv igm assay performs within specification.

• Brand Name: ELECSYS CMV IGM
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17984384
• Report Number: 1823260-2023-03388
• Device Sequence Number: 8166987
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K163569
• 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
• Report Date (Section B): 11/16/2023

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: 02/29/2024
• Device Catalogue Number: 07027133190
• Device Lot Number: 70633501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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