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 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous results for one patient sample tested for elecsys ft3 iii and the elecsys ft4 ii assay on a cobas e 411 immunoassay analyzer (e411).The erroneous results were reported outside of the laboratory.This medwatch will refer to the ft4 assay.Please refer to the medwatch.Patient identifier (b)(6) for information related to the ft3 assay.Refer to the attachment for all patient data.The sample was initially tested on the customer's e411 analyzer.The sample was provided for investigation where it was tested on a second e411 analyzer on (b)(6) 2018.The customer also tested the sample on an abbott architect analyzer.No adverse events were alleged to have occurred with the patient.The serial number of the e411 analyzer used at the customer site was asked for, but not provided.The e411 analyzer used for investigation was serial number (b)(6).Ft4 reagent lot number 303235, with an expiration date of february 2019 was used on this analyzer.Based on the provided data, a general reagent issue could most likely be excluded.Assays from different vendors can generate different values.This is related to the overall setups of the assays, the antibodies used, differences in reference materials, and differences in the standardization methodology used.The investigation was unable to find a definitive root cause.

• 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: 7722953
• MDR Text Key: 115546010
• Report Number: 1823260-2018-02473
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 04015630930920
• UDI-Public: 4015630930920
• 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: 07/26/2018

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 07/26/2018
• 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: 16 YR