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

Model Number RUBELLA IGG

Device Problem Non Reproducible Results (4029)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently ongoing.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.Erroneous non-reproducible results were generated by a cobas 8000 e 602 module and a cobas 8000 e 801 module.The event involved a total of 1 patient with the following: erroneous results for the elecsys rubella igg immunoassay the patient's age was (b)(6).There was one female.

Manufacturer Narrative

The customer provided the sample for investigation.The customer's results could be reproduced and the complaint could be confirmed.The investigation is ongoing.

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.There were no additional follow up actions for this event.

• Brand Name: ELECSYS RUBELLA IGG IMMUNOASSAY
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8544227
• MDR Text Key: 143403882
• Report Number: 1823260-2019-90108
• Device Sequence Number: 1
• Product Code: LFX
• UDI-Device Identifier: 04015630921423
• UDI-Public: 4015630921423
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup

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?: No
• Device Operator: No Information
• Device Model Number: RUBELLA IGG
• Device Lot Number: 37543301
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/28/2019; 01/15/2020
• Patient Sequence Number: 1