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	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medwatch fields a.Patient information, b6 relevant tests/laboratory data, and b7 other relevant history updated.On (b)(6) 2024, the customer reported that a new sample from patient 1 also gave discrepant elecsys cmv igm results: on (b)(6) 2023: the result from the cobas e 801 analytical unit was "negative".The result from the vidas analyzer was 1.09 cut-off index coi (positive).On (b)(6) 2024, the customer reported discrepant elecsys cmv igm results from a different patient (patient 2): on (b)(6) 2023: the result from the cobas e 801 analytical unit was "negative".The result from the vidas analyzer was 0.87 coi (positive).Investigation results: patient 1: the patient sample was received for investigation and was tested with the following: elecsys cmv igm and cmv igg - the customer's results were confirmed.Cmv igg avidity test - a higher result was obtained (investigation's result interpretation: gray zone; customer's result interpretation: low avidity).Cmv igg blot - broad antigen reactivity was detected with early and late phase antigens, which indicates cmv infection of >12 weeks ago.Elecsys cmv igg avidity assay - a slightly increasing cmv igg avidity was detected.The investigation determined that the results indicate a primary infection in the late acute infection phase based on the presence of increasing igg titers, an increasing cmv igg avidity, and a declining cmv igm reactivity; a secondary cmv infection or a cmv reactivation cannot be completely ruled out.Patient 2: the investigation determined that the patient's results indicate a late-stage cmv infection.Product labeling states "how does the cmv igm assay perform and what are its key features? in summary, the test is designed to detect acute infections where congenital risk lies." the investigation reviewed the handling and processing of patient 1's sample; no issues were noted.The investigation reviewed the calibration and qc data; the results were within specifications.The investigation did not identify a product problem.
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit is (b)(6).The patient sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys cmv igm results from several patient samples tested on the cobas e 801 analytical unit.The reporter was able to provide one patient sample with discrepant results: the patient was expected to be cmv igm positive based on the previous result from another laboratory that uses a vidas analyzer ( on (b)(6) 2024: 1.25 au/ml - positive).On (b)(6) 2024: the result from the analyzer was 0.571 cut-off index coi (negative/non-reactive).The result from the vidas analyzer was 1.23 coi (positive).

• 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: 19807365
• Report Number: 1823260-2024-02120
• Device Sequence Number: 7525396
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (Y/N): Y
• Initial Reporter Country: BE
• 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): 09/16/2024

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: 06/27/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 09/16/2024
• 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 Age: 31 YR
• Patient Sex: Female