MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS IGE II IMMUNOASSAY; RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E)

Catalog Number 04827031190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2015

Event Type  malfunction  

Manufacturer Narrative

A specific root cause could not be identified as insufficient patient sample was available for further investigation.The testing excluded a linearity issue or a "hook effect" in the sample.Interference was suspected, but could not be confirmed.The provided analyzer performance data was within specification and did not indicate a specific issue.

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.

Event Description

The customer received questionable immunoglobulin e (ige) results for one patient sample.The original sample result was 1519.0 iu/ml.The sample was tested with dilutions and the results were 6537.0 iu/ml (1:5), 8183.0 iu/ml (1:10) and 9156.0 iu/ml (1:50).Information concerning which result was reported outside the laboratory was requested, but was not provided.There was no adverse event reported.The ige reagent lot number was 175624.The expiration date was requested, but was not provided.Sample from the patient was submitted for investigation and the customer's results were reproduced.Based on the provided calibration and qc data, a general reagent issue was excluded.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

A new sample was drawn from the patient and the same phenomenon was observed.On (b)(6) 2015, the original immunoglobulin e (ige) result was 1511 iu/ml.With a 1:10 dilution, the result was 8313 iu/ml.This sample was submitted for further investigation.The patient was injected with "xolair (omalizumab, anti-human ige antibody, novartis)" for "rush oral immunotherapy.".

Manufacturer Narrative

Additional information concerning the patient was provided.The patient's height was (b)(6).The patient was given 525 mg of xolair once every 2 weeks.

• Brand Name: ELECSYS IGE II IMMUNOASSAY
• 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: 4479822
• MDR Text Key: 12833409
• Report Number: 1823260-2015-00814
• 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,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 01/16/2015
• 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: 013 YR
• Patient Weight: 39