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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer provided a sample of a patient with known questionable thyroid results to an investigation site for further investigation.At the investigation site there where discrepant results identified for elecsys tsh, elecsys ft4 ii, and elecsys ft4 iii between the investigation sites cobas e801 module, the investigation sites cobas e 411 immunoassay analyzer, and the abbott architect method.The customer did not provide any thyroid results from their analyzers.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the tsh results and medwatch with patient identifier (b)(6) for information on the ft4 iii.There was no allegation that an adverse event occurred.The e801 module serial number used at the investigation site was (b)(4).The e411 analyzer serial number used at the investigation site was (b)(4).The ft4 ii reagent lot number used with the e411 analyzer at the investigation site was 315901 with an expiration date of may-2019.The ft4 ii reagent lot number used with the e801 module at the investigation site was 303203 with an expiration date of apr-2019.Calibration and qc data at the investigation site were acceptable.From the data provided, a general reagent issue can be excluded.Assays from different manufacturers, in this case, abbott, can generate different results.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 8178358
• MDR Text Key: 131154536
• Report Number: 1823260-2018-04973
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 06437281190
• Device Lot Number: 315901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2018
• 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: 60 YR