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

Catalog Number 07027796190

Device Problem False Negative Result (1225)

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

Event Date 05/12/2022

Event Type  malfunction  

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 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.

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.

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
• Type of Device: 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
• MDR Text Key: 302177486
• Report Number: 1823260-2022-01620
• Device Sequence Number: 1
• Product Code: LFX
• UDI-Device Identifier: 04015630940257
• UDI-Public: 04015630940257
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K092322
• 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,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• 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 Catalogue Number: 07027796190
• Device Lot Number: 59615901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• 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