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 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient tested for immunoglobulin e (ige ii).It is not known if any erroneous results were reported outside of the laboratory.The initial ige ii result from a serum sample was 1555 iu/ml.The sample was repeated on (b)(6) 2015 and the result was 1487 iu/ml.The sample was diluted x2 and the result was >5000 iu/ml.The sample was diluted x10 and the result was 6906 iu/ml.On (b)(6) 2015, a new sample was obtained and the result from a serum sample was 1236 iu/ml.This sample was diluted x2 and the result was > 4454 iu/ml.The sample was diluted x10 and the result was 9154 iu/ml.On (b)(6) 2015, a new sample was obtained and the result from a serum sample was 1115 iu/ml.The sample was diluted x100 and the result was 13402 iu/ml.The results from a plasma sample were 1192 iu/ml.The sample was diluted x100 and the result was 13998 iu/ml.It is not known if the patient was adversely affected.No adverse event was reported.The e602 analyzer serial number was not provided.The sample from (b)(6) 2015 was sent in for investigation.The sample was sent to an external laboratory and the fluorescent enzyme immunoassay (feia) ige result was 2803 iu/ml.On (b)(6) 2015, a sample from a different patient was tested for ige ii and the result was approximately 2500 iu/ml.This patient's sample was sent to the investigation unit as a reference value.No further information is available about this patient.The sample was sent to an external laboratory and the feia ige result diluted x10 was 7004 iu/ml.

Manufacturer Narrative

The customer provided the patient samples in question and the reference sample for investigation.It was determined the patient samples contain anti-ige antibodies that aggregate with the ige molecules.This interference is addressed in product labeling.

• 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) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5233423
• MDR Text Key: 31571780
• Report Number: 1823260-2015-04579
• 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,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2016
• Device Catalogue Number: 04827031190
• Device Lot Number: 181429
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 11/05/2015
• 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: 056 YR