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

Catalog Number 06437281190

Device Problem High Test Results (2457)

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

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer received questionable high elecsys ft4 ii assay result for (b)(6) patient sample from a cobas e 411 immunoassay analyzer.The serial number was requested but was not provided.The initial result was 2.2 ng/dl and the repeat result from another roche analyzer in another laboratory was 1.82 ng/dl.The sample was repeated on an abbott architect analyzer and the result was 1.35 ng/dl.The erroneous result was reported outside of the laboratory.There was no allegation of an adverse event.

Manufacturer Narrative

Additional information was provided that the erroneous result was generated on (b)(6) 2017 and the repeat testing was performed on (b)(6) 2017 with an aliquot of the sample.Medwatch field was updated.As no sample material was available for further investigation, a specific root cause could not be identified.Additional information for further investigation was requested but was not provided.From the information provided, a general reagent issue could most likely be excluded.Differences between ft4 results generated on roche or abbott platforms can occur.This relates to the overall setups of the assays, the antibodies used, and differences in reference materials and the standardization methodology used.

• 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: 7012595
• MDR Text Key: 92610362
• Report Number: 1823260-2017-02561
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 12/17/2017

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: 185414
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 10/20/2017
• Supplement Dates FDA Received: 12/18/2017
• 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: 41 YR