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	08/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys cmv igg and elecsys cmv igm assay results from one patient sample tested on the cobas e 801 analytical unit.This medwatch is for the elecsys cmv igm assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for the elecsys cmv igg assay.Please refer to the attachment (b)(6) for the table containing the questionable results.
Additional Manufacturer Narrative
The investigation reviewed the (b)(6) 2024 calibration data and qc recoveries; the results were within specifications.The investigation reviewed the patient's results and determined that they indicated the patient was in an acute primary infection in the early phase.Product labeling states: "elecsys cmv igm result message - borderline: re-test the sample.If the result is still indeterminate (borderline), collect and test a second sample within the following 2 weeks." "elecsys cmv igm limitations - a negative cmv igm test result does not rule out the possibility of an acute infection with cytomegalovirus.Individuals at the early stage of acute infection may not exhibit detectable levels of cmv igm antibodies.The individual immune response following cmv infection varies considerably." the investigation did not identify a product problem.

• 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: 20370239
• Report Number: 1823260-2024-02892
• Device Sequence Number: 15149406
• 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): 11/05/2024

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: 12/31/2024
• Device Catalogue Number: 07027133190
• Device Lot Number: 76403201
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/05/2024
• 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