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

Catalog Number 06437281190

Device Problem Low Test Results (2458)

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

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer complained of erroneous results for 1 patient sample tested for elecsys tsh assay (tsh), elecsys ft4 ii assay (ft4 ii) and elecsys ft3 iii (ft3 iii) on a cobas 8000 e 602 module compared to the siemens centaur xp method at an external laboratory.The erroneous results were reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with (b)(6) for information on the tsh erroneous results and medwatch with (b)(6) for information on the ft3 iii erroneous results.There was no allegation that an adverse event occurred.The e602 module serial number was not provided.

Manufacturer Narrative

The patient sample was submitted for investigation.The customer's high ft4 ii and ft3 iii results were reproduced.The tsh results were within the reference range.Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This most likely caused the high ft4 ii and ft3 iii results.This interference is covered in product labeling.Product labeling states "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." it should be taken into account that tsh results can be different from different analyzers from different manufacturers.This relates to the overall setup of the assays, the antibodies used and differences in reference materials/methods and the standardization methodology used.The incidence rate of the identified interfering factor is monitored on a quarterly basis.

• 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: 7063211
• MDR Text Key: 93634833
• Report Number: 1823260-2017-02753
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 06437281190
• Device Lot Number: 22515001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2017
• 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: 13 YR