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

Catalog Number 04784618190

Device Problem False Negative Result (1225)

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

Event Date 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

The e602 module serial number was 1461-12.The competitor method was abbott.The sample from 1(b)(6) 2023 was submitted for investigation.The sample was tested on an e 602 module using cmv igm reagent lot 706329: the cmv igm result was 0.263 coi ( negative).The customer¿s negative result was reproduced during the investigation.Calibration signals from (b)(6) were acceptable.Qc data was acceptable.No issues were identified with the preanalytic information provided for the sample from (b)(6) 2023.The investigation is ongoing.

Event Description

The initial reporter complained of discrepant negative results for 2 samples from 1 patient tested for elecsys cmv igm (cmv igm) on a cobas 8000 e 602 module compared to a competitor method.The patient's clinical and diagnostic picture (virocytes, abnormal liver set) are compatible with acute cmv infection.The results from a competitor platform were serologically compatible.Sample 4023-381290: competitor cmv igg result was 10.8 au/ml (positive, threshold <6) competitor cmv igm result was 11.58 index (positive, threshold <0.85) on (b)(6) 2023, sample 4023-373521: elecsys cmv igm result was 0.250 coi (negative) competitor cmv igm result was positive.The specific result was not provided.On (b)(6) 2023, sample 4023-375576: elecsys cmv igm result was negative.The specific result was not provided.Competitor cmv igm result was positive.The specific result was not provided.On (b)(6) 2023, sample id unknown: elecsys cmv igm result was positive.The specific result was not provided.Due to the positive elecsys cmv igm result on (b)(6).2023, seroconversion is suspected.

Manufacturer Narrative

The sample from (b)(6) 2023 underwent further testing by the mikrogen cmv igm blot method and the result was negative.This corresponds to the elecsys cmv igm result.The additional samples from the customer site from (b)(6) 2023 and (b)(6) 2023 were not provided for investigation.The sample from (b)(6) 2023 was positive with the elecsys cmv igm assay which corresponds to the abbott cmv igm result.As the igm reactivity increased in sequential samples, a primary infection in the early phase was indicated.The root cause was determined to be early seroconversion.The elecsys cmv igm assay performs within specification.

• 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: 17967179
• MDR Text Key: 326077419
• Report Number: 1823260-2023-03353
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): Y
• Reporter Country Code: BE
• PMA/PMN Number: K142133
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• 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: 04784618190
• Device Lot Number: 706329
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• 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