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 02/10/2023

Event Type  malfunction  

Manufacturer Narrative

Calibration and qc were acceptable.The sample was requested for investigation.

Event Description

The initial reporter questioned negative results for 1 patient tested for elecsys cmv igg (cmv igg) and elecsys cmv igm (cmv igm) on a cobas e 801 module.This medwatch will cover cmv igm.Refer to medwatch with patient identifier (b)(6) for information on the cmv igg results.The initial cmv igg result from the e801 module was 0.180 u/ml (negative).The initial cmv igm result from the e801 module was 0.239 coi (negative).The initial results were reported outside of the laboratory.The patient went to another hospital.A new sample was obtained and the cmv igg and cmv igm results from the chorus diesse method were both positive (the actual results were not provided).The original sample was sent to an external laboratory for testing by the diasorin liason method and the cmv igg result was 16.7 u/ml (positive) and the cmv igm result was 80.3 coi (positive).On (b)(6) 2023 the customer repeated the original sample on the e801 module and the cmv igg result was 0.181 u/ml (negative) and the cmv igm result was 0.240 coi (negative).On (b)(6) 2023 the original sample was again repeated by the customer with a cmv igg result of 0.204 u/ml (negative) and a cmv igm result of 0.241 coi (negative).The original sample also underwent molecular antigen testing where the results were positive.The e801 module serial number was (b)(4).

Manufacturer Narrative

The two samples were further investigated by testing with the recomline cmv igg assay and the recomline cmv igm assay from mikrogen.Both samples tested positive for cmv igg and cmv igm.The results from the investigation suggest a primary infection in the early phase.The roche results showed increasing results with the 2nd sample.The negative results from the roche method may indicate a very early phase of infection.A new sample from the patient was obtained on (b)(6) 2023 and tested for cmv igm and cmv igg.The cmv igm result was negative.The specific result was not provided.The cmv igg result was 2.9 u/ml (positive).The investigation is ongoing.

Manufacturer Narrative

Based on the investigation results, the reagents perform within specification.The investigation did not identify a product problem.

Manufacturer Narrative

Section d4, catalog number was updated.Two samples from the patient were received for investigation (a sample from on (b)(6)2023 and a sample from on (b)(6) 2023).The samples were run on an e801 module where the cmv igg and cmv igm results were both negative.On (b)(6) 2023: cmv igm result was 0.284 u/ml (negative).Cmg igg result was 0.176 u/ml (negative).On (b)(6) 2023: cmv igm result was 0.54 u/ml (negative).Cmg igg result was 0.3 u/ml (negative).The customer's results were reproduced.The investigation is ongoing.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16516443
• MDR Text Key: 311568117
• Report Number: 1823260-2023-00749
• Device Sequence Number: 1
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 07027133190
• Device Lot Number: 63027501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• 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