MAUDE Adverse Event Report: ROCHE DIAGNOSTICS RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS; ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Catalog Number 04618793190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred in: (b)(6).

Event Description

The customer complained of questionable elecsys rubella igg (rub igg) immunoassay results for 3 separate samples from the same patient tested on a cobas e 411 immunoassay analyzer compared to the results from the elisa igg test method.On (b)(6) 2018 sample a rub igg result from the cobas e411 was 19.13 iu/ml, reactive.On (b)(6) 2018 sample b rub igg result from the cobas e411 was 19.09 iu/ml, reactive.On (b)(6) 2018 sample c rub igg result from the cobas e411 was 16.48 iu/ml, reactive.For samples a, b, and c the elisa igg test results were negative.The erroneous results were released outside of the laboratory to both the patient and their doctor.There was no allegation of an adverse event.The patient has no medical history of rubella disease or vaccination.The cobas e411 serial number was (b)(4).It was stated that the customer rarely runs qc testing.The customer had run qc testing on (b)(6) 2018 with acceptable results.From the information provided, it appears the rub igg reagent lot used for the (b)(6) 2018 result was lot 267421, and the rub igg reagent lot used for the (b)(6) 2018 results was lot 28366401 with an expiration date of 30-sep-2018.The investigation is currently ongoing.

Manufacturer Narrative

A new sample was drawn from the patient and the customer's rub igg result was "around 14 iu/ml" and was rubella igm negative.The sample was submitted for investigation and results comparable to the customer¿s results were obtained.The investigation is ongoing.

Manufacturer Narrative

The sample was investigated with the recomblot rubella test and was positive.A neutralization test successfully neutralized the sample, strongly supporting the rubella igg positive status of the sample.The positive sample result was correct.It was reactive in the elecsys rubella igg assay.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7897455
• MDR Text Key: 120982696
• Report Number: 1823260-2018-03222
• Device Sequence Number: 1
• Product Code: LFX
• UDI-Device Identifier: 04015630921423
• UDI-Public: 4015630921423
• 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,Followup
• Report Date: 11/05/2018

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 Catalogue Number: 04618793190
• Device Lot Number: 267421
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 09/04/2018; 09/04/2018
• Supplement Dates FDA Received: 10/08/2018; 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR