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

Catalog Number 04784596190

Device Problem Low Test Results (2458)

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

Event Date 06/10/2022

Event Type  malfunction  

Manufacturer Narrative

The customer provided the patient's sample for an investigation.The investigation tested the patient's sample on a cobas e 411 immunoassay analyzer and had the following results: elecsys cmv igm: 3.14 coi reactive.Elecsys cmv igg: 1.0 u/ml reactive.The investigation could not confirm the customer's cmv igg results.The investigation reviewed the customer's provided qc results and the results were within the acceptable range.However, there were no qc results provided on the date of the event.Per product labeling, "the measured cmv igg value of a patient¿s sample can vary depending on the testing procedure used.The laboratory finding must therefore always contain a statement on the cmv igg assay method used.Cmv igg values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.Therefore, the results reported by the laboratory to the physician should include: "the following results were obtained with the elecsys cmv igg assay.Results from assays of other manufacturers cannot be used interchangeably." for borderline results, product labeling states, "re-test the sample, collect another sample within 2 weeks or test with an alternative method." the investigation is ongoing.

Event Description

The initial reporter received questionable elecsys cmv igg results for one patient tested on a cobas e411 disk serial number (b)(4).The patient's elecsys cmv igg results were not reported outside the laboratory.The customer performed repeat testing with the sample on the e411 analyzer.The customer sent the sample to two different laboratories and the sample was tested on siemens analyzers.The patient's initial elecsys cmv igg result was 0.818 u/ml indeterminate.The patient's repeat elecsys cmv igg result was 0.797 u/ml indeterminate.The patient's cmv igg results on the siemens analyzers were positive.The specific cmv igg results were requested but not provided.

Manufacturer Narrative

The investigation tested the sample with mikrogen recomline methodology: the patient's mikrogen recomline cmv igg result was reactive.The patient's mikrogen recomline cmv igm result was reactive.The customer¿s result could not be reproduced.The elecsys cmv igg assay showed a low reactivity.A primary infection in the early phase was indicated due to the presence of igm antibodies, but the absence of high igg titers.Analysis of a follow-up sample would help to detect an advanced seroconversion.The investigation determined a general product problem was not found.

• Brand Name: ELECSYS CMV IGG
• 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: 14982565
• MDR Text Key: 304529643
• Report Number: 1823260-2022-02045
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K131605
• 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: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 04784596190
• Device Lot Number: 55766300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• 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