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

Catalog Number 11930419122

Device Problem High Test Results (2457)

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

Event Date 08/01/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable immunoglobulin e (ige) results for one patient from an unknown roche analyzer.The initial result was flagged as greater than the test range and the sample was reanalyzed with a 1:20 dilution.The result that was released was 44,000 iu/ml.Two weeks later on an unspecified date, the patient had ige tested at another hospital using the beckman coulter image and the result was 125 iu/ml.The patient's doctor asked why the initial result did not correlated with what the other hospital released.On (b)(6) 2015, the patient was retested and the result was 2500 iu/ml flagged as greater than test range.When tested with a 1:20 dilution, the result was 50,000 flagged as greater than test range.On (b)(6) 2015, the pathologist decided to check serum protein electrophoresis and the gamma levels were normal.She expected them to be elevated due to high ige levels.The pathologist believed the results were not correct.On (b)(6) 2015, a sample from the patient was tested at another site using a cobas e601 analyzer and the result was 2500 iu/ml flagged as greater than the test range.When diluted 1:20, the result was 49448 iu/ml.No adverse event adverse event was reported.

Manufacturer Narrative

The analyzer involved was a cobas e601.Information was provided concerning the results: "1st run within institution around 40000 iu/ml (cobas 6000) 1st extraction 2nd run different institution roughly 140 iu/ml (beckman coulter immage) 2nd extraction 3rd run within institution around 40000 iu/ml (cobas 6000) 3rd extraction 4th run different institution with roche cobas 6000 same sample as with 3rd extraction".

Manufacturer Narrative

A sample from the patient was submitted for investigation and the customer's results could be reproduced.

Manufacturer Narrative

Sample from the patient was submitted for investigation and the customer's results were confirmed on a cobas e601 and a siemens centaur analyzer.Based on these results, it was believed the result from the beckman coulter was likely incorrect.A general reagent issue with the roche ige assay could be excluded.

• 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: 5134659
• MDR Text Key: 27823110
• Report Number: 1823260-2015-04291
• Device Sequence Number: 1
• Product Code: JHR
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K984326
• 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: Followup,Followup,Followup
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2016
• Device Catalogue Number: 11930419122
• Device Lot Number: 181429
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 09/20/2015
• 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: 049 YR