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

Catalog Number ASKU

Device Problem High Test Results (2457)

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

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for two samples from the same patient tested for the elecsys ft4 ii assay (ft4) on a cobas 6000 e 601 module (e601).No erroneous results were reported outside of the laboratory.Refer to the attachment for all patient data.A first sample, dated (b)(6) 2017, was tested at the customer site for tsh on a roche diagnostics elecsys e170 modular analytics immunoassay analyzer (e170).Two more samples, dated (b)(6) 2017 and (b)(6) 2017, were collected from the patient and tested on a centaur analyzer.These 2 samples were then provided for investigation, where they were tested on the e601 analyzer on (b)(6)2017.No adverse events were alleged.The serial number of the e170 analyzer used at the customer site was (b)(4).The serial number of the e601 analyzer used for investigation was (b)(4).The ft4 reagent lot number used on this analyzer was 265631, with an expiration date of september 2018.The samples dated (b)(6) 2017 and (b)(6) 2017 were provided for further investigations.The centaur values and e601 values were duplicated.Further investigations of the samples determined that they did not contain any interfering factors that would affect the ft4 assay.Concerning the mathematical differences of the ft4 values, assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and the standardization methodology used.The normal reference ranges used by different assay vendors can also be different.This is related to the population used and the calculation mode.A general reagent issue was excluded based on the measured values.No product problem was found.

• Brand Name: ELECSYS FT4 II ASSAY
• 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: 7137693
• MDR Text Key: 95829792
• Report Number: 1823260-2017-03085
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2017

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: ASKU
• Device Lot Number: 265631
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/21/2017
• 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: 77 YR