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	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable elecsys cmv igm (cmv igm) result from one patient sample tested on the cobas e 801 analytical unit.The reporter confirmed the initial result using a mini vidas analyzer.The initial result from the analyzer was 0.35 cut-off index coi (negative).The repeat result from the mini vidas analyzer was 1.28 (positive).The patient is suspected to have cytomegalovirus (cmv) infection.
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit is (b)(4).The investigation is ongoing.
Additional Manufacturer Narrative
The patient sample was not available for investigation.A statement was provided that the qc and calibration were considered correct.Product labeling states "in some individuals non-reactive results may occur in the late phase of acute infection by the elecsys cmv igm assay.As with any in vitro diagnostic test, false results may occur." 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: 17744102
• Report Number: 1823260-2023-02977
• Device Sequence Number: 5654238
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (Y/N): Y
• Initial Reporter Country: AL
• 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): 10/13/2023

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: 706335
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/13/2023
• 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: Female