MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IMMUNOGLOBULIN E; RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E)

Catalog Number 04827031190

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 02/09/2015

Event Type  malfunction  

Manufacturer Narrative

A sample from the patient was investigated and the customer's results were confirmed.The patient was injected with xolair (omalizumab, anti-human ige antibody, novartis) for "rush oral immunotherapy.".

Manufacturer Narrative

As part of the investigation, xolair was added to human ige samples and the results compared with a drug free control sample.The spiked samples showed reduced recovery of ige.A pharmacological interference with the assay was confirmed.

Manufacturer Narrative

Additional information was provided concerning the patient.The patient's height was (b)(6).The patient was taking 300 mg/day of xolair once every two weeks from (b)(6) 2014 through current day.

Event Description

The customer received questionable immunoglobulin (ige) results for one patient sample from an unknown roche analyzer.Original first result was 1701.0 iu/ml, repeat result was 1799.0 iu/ml.Auto dilution 1:5 result was 938.4 iu/ml (calculated 4692.0 iu/ml).Auto dilution 1:10 result was 509.8 iu/ml (calculated 5098.0 iu/ml).Manual dilution 1:50 result was 113.8 iu/ml (calculated 5690 iu/ml).Information concerning which result was reported outside the laboratory or if the patient was adversely affected was requested, but was not provided.

Manufacturer Narrative

This event occurred in (b)(6).

• Brand Name: IMMUNOGLOBULIN E
• Type of Device: RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4542108
• MDR Text Key: 13000825
• Report Number: 1823260-2015-01504
• Device Sequence Number: 1
• Product Code: JHR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2015
• Device Catalogue Number: 04827031190
• Device Lot Number: 175624
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 02/10/2015
• 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
• Patient Sequence Number: 1
• Patient Age: 008 YR
• Patient Weight: 23