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

Catalog Number 04618793160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that they received false positive results for two samples from the same patient tested for igg antibodies to rubella virus (rubigg) on an e601 analyzer.The first sample resulted as 26.79 ui/ml, which is considered a reactive (positive) result.This result was reported outside of the laboratory.A previous result of this test from another laboratory was negative, so an aliquot of the sample was sent to another laboratory for repeat testing.The repeat result from the other laboratory was negative.A second sample was tested on(b)(6) 2015 resulting as 24.40 ui/ml for rubigg.The 24.40 ui/ml value is considered to be reactive (positive).This sample was sent to another laboratory, where it was tested and resulted as 6 ui/ml.The 6 ui/ml value is considered to be a negative value.The patient was not adversely affected.The e601 analyzer serial number was (b)(4).

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations of the sample have concluded that the result was correctly positive for rubella igg.

• Brand Name: IGG ANTIBODIES TO RUBELLA VIRUS
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5087233
• MDR Text Key: 26256216
• Report Number: 1823260-2015-04195
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: Followup
• Report Date: 10/23/2015

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: 11/30/2015
• Device Catalogue Number: 04618793160
• Device Lot Number: 182963
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2015
• 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: 029 YR
• Patient Weight: 56