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

Catalog Number 07027133190

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The serial number of the customer's cobas e 801 analytical unit is (b)(4).The investigation is ongoing.

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
• Type of Device: 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
• MDR Text Key: 323382099
• Report Number: 1823260-2023-02977
• Device Sequence Number: 1
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (y/n): Y
• Reporter Country Code: AL
• PMA/PMN Number: K163569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female