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

Model Number RUBELLA IGG

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 07/25/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient tested with elecsys rubella igg and elecsys rubella igm on a cobas e 411 immunoassay analyzer.The results did not agree with values measured on a siemens analyzer.The elecsys results were reported outside of the laboratory.This medwatch will apply to the rubella igg assay.Please refer to the medwatch with patient identifier pt-72620 for information related to the rubella igm assay.The sample was tested on the e411 analyzer, resulting in the following values: run 1 on (b)(6) 2022: rubella igg = 20.67 iu/ml (reactive), rubella igm = 0.407 coi (non-reactive) run 2 on (b)(6) 2022: rubella igg = 23.71 iu/ml (reactive), run 3 on (b)(6) 2022: rubella igg = 23.46 iu/ml (reactive), rubella igm = 0.415 coi (none-reactive).The sample was repeated on a siemens analyzer, resulting in the following values: rubella igg = 4.79 iu/ml (non-reactive).Rubella igm = 3.6 (no unit provided, reactive).The patient's avidity was negative.The customer noted that the patient had similar values with the siemens method prior to the patient's pregnancy.The same patient sample was tested with an unknown rubella igm elisa test, which resulted as negative.The patient is "probably" vaccinated.No further information could be provided any further information.The patient has had no known rubella infection in the past.The patient had no symptoms.Amniocentesis was performed on the patient based on the siemens rubella igm result.Pcr testing was performed on the patient's amniotic fluid and this was negative for rubella rna.The amniocentesis took place on the 20th week of patient pregnancy (2nd trimester).The serial number of the e411 analyzer is (b)(4).

Manufacturer Narrative

The patient sample was provided for investigation.Upon initial investigation of the sample, the customer's results could be reproduced.Investigations are ongoing.

Manufacturer Narrative

Further investigations were not able to conclude the patient's status of infection.A follow up sample was requested for further investigations, but none were provided.The investigation could not identify a product problem.The cause of the event could not be determined.The reagent performed within specification.

• Brand Name: ELECSYS RUBELLA IGG
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• 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: 15286858
• MDR Text Key: 305510967
• Report Number: 1823260-2022-02530
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K072617
• 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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 04618793190
• Device Lot Number: 58677701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• 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
• Patient Age: 39 YR
• Patient Sex: Female