MAUDE Adverse Event Report: ROCHE DIAGNOSTICS T4; RADIOIMMUNOASSAY, TOTAL THYROXINE

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained that thyroid tests run by the roche method did not meet the clinical picture for 1 patient tested for free thyroxine (ft4 ii), free triiodothyronine (ft3), triiodothyronine (t3), thyroxine (t4) and antibodies to tsh receptor (anti-tshr).The thyroid values from the abbott method were normal.It is not known if erroneous results were reported outside of the laboratory.A customer in (b)(6) sent the patient sample along with an email to a biochemist in a (b)(6) hospital.Information regarding this event came to the manufacturer from the (b)(6) hospital.The manufacturer is attempting to gather more details.This medwatch will cover t4.Refer to medwatch with (b)(6) for information on the ft4 ii erroneous results, medwatch with (b)(6) for information on the ft3 erroneous results, medwatch with (b)(6) for information on the t3 erroneous results, and medwatch with (b)(6) for information on the anti-tshr erroneous results.Testing performed by the (b)(6) customer determined the ft4 ii and ft3 results were very high, the t3 and t4 results were 3-4 times the normal range and the anti-tshr results were 10 times the normal range with the roche method.The tsh results for this patient were normal with the roche method and her past thyroid function was normal.The patient has no symptoms of hyperthyroidism.The customer suspects an interference in the sample.The (b)(6) hospital tested the sample on an abbott architect i2000 and the ft3, ft4 ii and tsh values were normal.The actual results were not provided.The anti-tshr result from the ria brahms method was 1.9 ul/l which is in the grey zone of that assay.The sample was also treated with hbt scantibodies and tested for human anti-mouse antibodies (hama) and the result was negative.No repeat test results have been provided for the t3 and t4 tests.No adverse event occurred.The tests by the roche method were performed on an e601 analyzer.The serial number was not provided.

Manufacturer Narrative

Due to lack of sample volume, further investigation of t4 could not be performed.The elevated t4 values could be affected by the presence of a streptavidin interfering factor previously identified for the ft4 and ft3 parameters.This specific interference is addressed in product labeling.

• Brand Name: T4
• Type of Device: RADIOIMMUNOASSAY, TOTAL THYROXINE
• 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: 5454928
• MDR Text Key: 38857691
• Report Number: 1823260-2016-00204
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2016
• 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