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 Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for one patient sample tested for elecsys ft3 iii (ft3) and the elecsys ft4 ii assay (ft4) on a cobas 8000 e 602 module (e602).It was asked, but it is not known if the erroneous results were reported outside of the laboratory.This medwatch concerns the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay.The customer collected the sample on (b)(6) 2017 and it was tested on their e602 analyzer on (b)(6) 2017.The sample was then provided for investigation, where it was tested on a second e602 analyzer and a cobas e 411 immunoassay analyzer (e411).No adverse events were alleged to have occurred with the patient.The serial number of the e602 analyzer used at the customer site was asked for, but not provided.The serial number of the e602 analyzer used for investigation was (b)(4).The ft4 reagent lot number 265631, with an expiration date of september 2018 was used on this analyzer.The serial number of the e411 analyzer used for investigation was (b)(4).The ft4 reagent lot number 265631, with an expiration date of september 2018 was used on this analyzer.Calibration and quality control recoveries related to investigation testing were ok.The ft4 values generated at the customer site and during investigations are considerably different.The ft4 value generated at the customer site may represent either a non-reproducible low result or a non-reproducible high result.Further investigation of the difference in ft4 values was not possible based on the provided information.Further investigation also was not possible since there was no remaining sample volume available.Based on the similarity of ft3 and tsh values generated at the customer site and during investigations, a sample mix up can most likely be excluded.Based on the information provided, a general reagent issue can most likely be excluded.

• 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: 7042361
• MDR Text Key: 93305201
• Report Number: 1823260-2017-02659
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2017

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: 06437281190
• Device Lot Number: ASKU
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/17/2017
• 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