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

Catalog Number 07027117190

Device Problem High Test Results (2457)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The patient's sample was provided for an investigation.The investigation is ongoing.Unique device identifier (udi): (b)(4).

Event Description

The initial reporter received questionable elecsys cmv igg assay results for one patient tested on a cobas 8000 e 801 module serial number (b)(4).The patient's initial elecsys cmv igg result was reported outside the laboratory.The patient's physician questioned the elecsys cmv igg result due to the result not matching the patient's clinical status.The customer repeated the sample on a mikrogen recom line wester blot analyzer.Also, the patient's sample was sent to a different laboratory and was tested on an e 801 module.On (b)(6) 2021, the patient's initial elecsys cmv igg result was 1.32 u/ml reactive.The patient's repeat cmv igg result on the mikrogen recom line wester blot analyzer was non-reactive.The date of measurement was requested but not provided.On (b)(6) 2021, the patient's second repeat cmv igg result on a different e 801 module was 1.24 u/ml reactive.

Manufacturer Narrative

The customer's calibration and qc data were requested but not provided.The investigation performed further testing with the patient's sample.The patient's recomline cmv igg was negative.The patient's cmv igg submodule assay result was dominant reactivity to module 4.The investigation determined the sample caused a false reactive result with the elecsys cmv igg assay due to an unspecified interferent.The patient should be considered seronegative for cmv.Based on the specificity of the elecsys cmv igg assay, false positives can occur.The investigation did not identify a product problem.

Manufacturer Narrative

The investigation tested the patient's sample and received the following results: cmv igm: 0.143 coi non-reactive cmv igg: 1.35 u/ml reactive cmv igg avidity: 84.3 % the investigation confirmed the customer's results.Based on the available information, a general reagent issue could be excluded.The investigation is ongoing.

• Brand Name: ELECSYS CMV IGG ASSAY
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11672502
• MDR Text Key: 269787721
• Report Number: 1823260-2021-01149
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• PMA/PMN Number: K131605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07027117190
• Device Lot Number: 52258300
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR