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 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Medwatch field phone number was provided as "(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 6000 e 601 module.No incorrect results were reported outside of the laboratory.The sample resulted with a rubella igg value of 7.24 coi (non-reactive) when tested on the e 601 analyzer.The sample was repeated using the diesse elisa rubella igg method, resulting with a value of 42 ui/ml (positive).The serial number of the e 601 analyzer is (b)(4).

Manufacturer Narrative

Calibration signals were within expected ranges.Quality controls were within specified ranges.Samples from the patient were provided for investigation and the results obtained by the customer could be reproduced.Investigation of the sample performed with a competitor test determined the complained sample was clearly reactive for rubella igg.The sample did not contain any interfering factors.The patient is regarded as anti-rubella igg low positive.The complained sample is regarded as false negative, however, close to the cut-off of the assay (10 iu/ml).The rubella igg reagent performs within specification.Product labeling states: "a test result < 10 iu/ml does not completely rule out the possibility of an acute rubella infection.Specimens taken very early in the acute phase of infection may not contain any detectable amounts of rubella igg antibodies or may have an antibody concentration < 10 iu/ml." for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other finding.

• 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: 10958488
• MDR Text Key: 244328686
• Report Number: 1823260-2020-03110
• 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: 01/27/2021

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 Expiration Date: 02/28/2021
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 04618793190
• Device Lot Number: 446454
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR