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

Model Number RUBELLA IGG

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received a false negative result for one patient sample tested with the elecsys rubella igg immunoassay on a cobas 8000 e 602 module.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.The sample resulted with a rubella igg value of 6.63 iu/ml (non-reactive) when tested on the e 602 analyzer.The sample was repeated using the vidas rubella igg assay, resulting with a value of 28 (positive, no units provided).The serial number of the e 602 analyzer is (b)(4).

Manufacturer Narrative

A sample from the patient was provided for investigation.The results obtained by the customer could be reproduced.Further investigations of the sample performed with the platelia rubella igg assay and the mikrogen recomblot rubella igg determined the sample was reactive.The recovery with the elecsys rubella igg assay was determined to be false negative.Single false non-reactive results can occur due to the claimed sensitivity of the assay.The reagent performs within specifications.

• 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 0457
• MDR Report Key: 10689735
• MDR Text Key: 242651003
• Report Number: 1823260-2020-02559
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• PMA/PMN Number: K072617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

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
• Device Operator: Health Professional
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 04618793190
• Device Lot Number: 443879
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1