MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FT4, FREE THYROXINE; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they had erroneous results for one patient sample tested for free thyroxine (ft4) and thyrotropin (tsh).The customer stated that the ft4 result was high, but the patient had normal tsh and ft3 results.The patient also was said to have a normal phenotype and the patient's ft4 result was expected to be normal.When compared to results from an abbott architect analyzer, the ft4 and tsh results from roche analyzers were higher.This medwatch will cover ft4.Please refer to the medwatch with patient identifier (b)(6)for information related to tsh.When tested on an e601 analyzer at the customer site, the sample resulted as 27.88 pmol/l for ft4 and 3.12 uiu/ml for tsh.The sample was repeated on an e602 analyzer at a different site, resulting as 30.76 pmol/l for ft4 and 3.15 uiu/ml for tsh.The sample was also repeated on an abbott architect analyzer, resulting as 14.9 pmol/l for ft4 and 2.16 miu/l for tsh.The patient was not adversely affected.The serial number of the customer's e601 analyzer was (b)(4).The serial number of the used e602 analyzer was asked for, but not provided.The patient sample was provided for investigation and it was confirmed that the ft4 result was above the reference range for the assay.The tsh result was confirmed to be within the normal range for the assay.No interfering factors, including t4 autoantibodies, were found to be present within the sample.A specific root cause could not be determined.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE 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: 5630318
• MDR Text Key: 44387054
• Report Number: 1823260-2016-00587
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K961489
• 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: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06437281190
• Device Lot Number: 187609
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/04/2016
• 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: NO MEDICATION
• Patient Age: 44 YR