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

Catalog Number 07027770190

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of discrepant results for 1 patient sample tested for elecsys rubella igg immunoassay (rubella igg) on a cobas e 801 module.The discrepant results are from 2 different reagent lots and the customer is not sure which result is correct as the patient was considered "immunized" using 1 reagent lot and "not immunized" from the other reagent lot.The customer also decided to reanalyze 20 samples from other patients on the 2 different reagent lots of rubella igg and one additional reagent lot of rubella igg.These samples were also sent to an external laboratory and tested by the siemens and blot method.Based on the data provided, the results for 11 patient samples were discrepant between the rubella igg reagent lots and the siemens and blot methods.Refer to the attached data for these additional patient results.This medwatch will cover rubella igg reagent lot 267449.Refer to medwatch with patient identifier (b)(6) for information on rubella igg reagent lot 206165 and medwatch with patient identifier (b)(6) for information on rubella igg reagent lot 282957.The patient had been tested on (b)(6) 2017 with reagent lot 206165 and the rubella igg result was 15 ui/ml (positive).When the patient was tested in (b)(6) 2018 with reagent lot 267449 the rubella igg result was 6.56 ui/ml (negative).On (b)(6) 2018 the customer repeated the patient sample from (b)(6) 2017 using reagent lot 267449 and the result was 8.23 ui/ml (negative).On (b)(6) 2018 the customer ran the patient sample from (b)(6) 2017 with reagent lot 267449 and the result was 8.83 ui/ml (negative).No comparison results were provided for this sample.On (b)(6) 2018 the customer ran the patient sample from (b)(6) 2017 with reagent lot 267449 and the result was 7.03 ui/ml (negative).No comparison results were provided for this sample.There was no allegation that an adverse event occurred.The e801 serial number was not provided.

Manufacturer Narrative

Based on the information available, a general reagent issue is not suspected.Product labeling comprehensively describes and addresses the issue of lot-to-lot variability and how to handle patient results that are close to the cut off.A product problem was not detected.The investigation was unable to find a definitive root cause for this event.

• 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
• 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: 7233477
• MDR Text Key: 99005436
• Report Number: 1823260-2018-00292
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07027770190
• Device Lot Number: 267449
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2018
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR