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

Model Number IGE

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient sample tested for immunoglobulin e (ige ii).It is not known if erroneous results were reported outside of the laboratory.The initial ige ii result was 925.00 iu/ml.The sample was diluted x5 and the result was >12,500.00 iu/ml.The sample was diluted x400 and the result was 163,623.00 iu/ml.No adverse event occurred.The e602 analyzer serial number was not provided.

Manufacturer Narrative

The patient sample was submitted for investigation.During the investigation the customer's results were reproduced.The very high ige ii results causes a high dose hook effect as described in product labeling.Based on the investigation data, a general reagent issue can be excluded.

• Brand Name: IMMUNOGLOBULIN E
• Type of Device: RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E)
• 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: 5532914
• MDR Text Key: 41425415
• Report Number: 1823260-2016-00369
• 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,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IGE
• Device Catalogue Number: 04827031190
• Device Lot Number: 181429
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2016
• 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