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

Catalog Number 06437281190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of erroneous results from 1 patient tested for elecsys ft4 ii assay (ft4 ii), elecsys tsh assay (tsh) and elecsys ft3 iii (ft3 iii).The erroneous results were reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the tsh erroneous results and medwatch (b)(6) for information on the ft3 iii results.Refer to the attached data for the patient results.No adverse event occurred.The e411 analyzer serial number was (b)(4).Based on a review of the calibration data, the signals were low for ft4 ii, tsh and ft3 iii.Quality controls (qc) were acceptable.Based on the information available for investigation, a general reagent issue at the customer site can most likely be excluded.The investigation noted that the measuring cell has more than (b)(4) counts.The fse visited the customer site to perform system tests.New calibration and new qc was acceptable.The customer thinks there might be heterophile antibodies in the patient sample.

Manufacturer Narrative

The sample from (b)(6) 2016 was submitted for investigation.The customer's low ft4 ii results were confirmed.Further investigation of the sample confirmed the sample contained an immunoglobulin that reacts with the reagent which affects the ft4 ii results.This interference is documented in product labeling.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.

• 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: 6057704
• MDR Text Key: 58412082
• Report Number: 1823260-2016-01636
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• 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: 125827
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• 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