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

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	05/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The qc results from the date of the event were acceptable.A sample from the patient was submitted for further investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable false-negative rubella igm elecsys result from cobas e 801 module serial number (b)(4).The result was 0.643 (non-reactive).The patient was also tested on a vidas instrument and the result was positive.The same sample was also tested on cobas e601 instrument and the result was non-reactive.The questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
Clarification was received that the sample was tested on the vidas analyzer on (b)(6) 2022.The same sample was then tested on the cobas e601 instrument on the same day.The next day, (b)(6) 2022, the same sample was tested on the cobas e 801 module.Medwatch field b3 - date of event was updated.A sample from the patient was submitted for investigation.The elecsys rubella igm non-reactive result was confirmed at 0.78 coi.The elecsys rubella igg was non-reactive at 0.210 iu/ml with a data flag.The investigation is ongoing.
Additional Manufacturer Narrative
The provided patient sample was further tested with the platelia rubella igm assay and the mikrogen recomblot rubella igg assay.The platelia rubella igm assay was positive and the recomblot rubella igg was negative with no bands at all.It was determined the rubella igg negativity and the positive result in the platelia rubella igm do not exclude a true positive rubella igm for this sample.The elecsys rubella igm was enhanced and found close to the grey zone.The elecsys rubella igm assay performs within specification.

• Brand Name: ELECSYS RUBELLA IGM
• Common Device Name: RUBELLA VIRUS IMMUNOGLOBULIN M (IGM) ANTIBODY IVD, KIT
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14602905
• Report Number: 1823260-2022-01620
• Device Sequence Number: 17686350
• Product Code: LFX
• UDI-Device Identifier: 04015630940257
• UDI-Public: 04015630940257
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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,Followup
• Report Date (Section B): 08/26/2022

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: 10/31/2022
• Device Catalogue Number: 07027796190
• Device Lot Number: 59615901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 06/06/2022; 08/01/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 06/28/2022; 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown