MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS RUBELLA IGM; RUBELLA VIRUS IMMUNOGLOBULIN M (IGM) ANTIBODY IVD, KIT, CHEMILUMINESCENT IMMUNOA

Catalog Number	07027796190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of false negative elecsys rubella igm results from the cobas e 801 module.The initial result was 0.501 coi (non-reactive).The customer repeated the sample with another methodology (elfa), and the result was 1.318 coi (reactive).The sample was repeated via clia methodology, and the results were 3.83 coi and 3.77 coi (reactive).On (b)(6) 2025, the repeat result was 0.577 coi (non-reactive).
Additional Manufacturer Narrative
The cobas e 801 module serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Sample material from the patient was received for investigation, and the customer's results were reproducible.Elevated rubella igm antibody levels may persist after natural infection and also after vaccination for a variable time period.Further tests or a combination of test methods should be done for clarification.The diagnosis of acute rubella infection may be supported by a significant increase in the anti-rubella igg titer from a first to a second sample.There was no product problem found.

• Brand Name: ELECSYS RUBELLA IGM
• Common Device Name: RUBELLA VIRUS IMMUNOGLOBULIN M (IGM) ANTIBODY IVD, KIT, CHEMILUMINESCENT IMMUNOA
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22554783
• Report Number: 1823260-2025-02222
• Device Sequence Number: 9576999
• Product Code: LFX
• UDI-Device Identifier: 04015630940257
• UDI-Public: 04015630940257
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K092322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: 07027796190
• Device Lot Number: 832273
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/28/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Female