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

Catalog Number 04827031190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2015

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 from the modular e analyzer was 106350 ku/l.The repeat result from a siemens centaur instrument was 420 ku/l.The ige from an electrophoresis was normal.No adverse event occurred.The modular e analyzer serial number was (b)(4).It was noted that liquid flow cleaning is performed every 2 weeks.

• 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; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5390208
• MDR Text Key: 36806824
• Report Number: 1823260-2016-00074
• Device Sequence Number: 1
• Product Code: JHR
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• 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: 188637
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2016
• 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
• Treatment: THE PATIENT TAKES NO MEDICATION.
• Patient Age: 52 YR