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 Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer complained of a false positive result for 1 pregnant patient tested for elecsys rubella igg immunoassay (rubella igg) on a cobas 6000 e 601 module.It is unclear if the positive result was reported outside of the laboratory.On (b)(6) 2017 the patient had a rubella igg result on the e601 module of 24.30 iu/ml (positive).On (b)(6) 2017 the patient had a rubella igg result on the e 601 module of 24.29 iu/ml (positive).The sample from (b)(6) 2017 was tested by the siemens method and the result was 4.43 iu/l (negative).The sample from (b)(6) 2017 was also tested by recomblot mikrogen and the conclusion was "traces" with a conclusion of uncertain presence of antibody.The patient is considered non-immune.There was no allegation that an adverse event occurred.The e601 module serial number was not provided.Samples from the patient were submitted for investigation.The customer¿s results from the sample from (b)(6) 2017 and the sample from (b)(6) 2017 were reproduced with results of 25.66 iu/ml (positive) and 22.86 iu/ml (positive) respectively.Investigations are ongoing.

Manufacturer Narrative

The customer's calibration and qc results were acceptable.Samples from the patient were investigated further.The sample from (b)(6) 2017 was tested by the platelia rubella igg method and the result was 2.18 iu/ml (negative).The sample was tested by recomblot rubella igg and the result was indeterminate.The sample was also tested with an in-house neutralization assay for rubella igg and the sample was neutralizable and therefore positive.During the preliminary investigation, the customer's results were confirmed as positive.During further investigation of the sample, differing results were received resulting in an overall outcome of indeterminate.The platelia rubella igg was found to be negative, although clearly above background (negative samples usually have values < 1.0 iu/ml).The recomblot method showed indeterminate reactivity.The neutralization assay result strongly indicates the presence of specific anti-rubella igg antibodies.This is supported by the customer's results.A specific root cause was not identified.Based on the information available, the assay performs within specification.

• 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: 7078563
• MDR Text Key: 94847390
• Report Number: 1823260-2017-02812
• 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: 02/06/2018

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: 206194
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/04/2017
• Supplement Dates Manufacturer Received: 11/16/2017
• Supplement Dates FDA Received: 02/06/2018
• 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