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 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer stated that they received erroneous results for one patient sample tested for the elecsys tsh assay, elecsys ft3 iii, and elecsys ft4 ii assay on a cobas 6000 e 601 module (e601).This medwatch will apply to the ft4 assay.Patient identifier (b)(6) for information related to the tsh assay.Patient identifier (b)(6) for information related to the ft3 assay.The sample was tested on both the e601 analyzer and an architect analyzer (clia method).Information concerning if any erroneous results was reported outside the laboratory was requested, but it was unknown.There was no allegation of an adverse event.The e601 analyzer serial number was (b)(4).

Manufacturer Narrative

Based on the provided calibration and control data, a general reagent issue can most likely be excluded.A sample from the patient was not available, so further investigations were not possible.Concerning the observed result differences, a biological component may be present in the sample that may differently interact with the assay components of either the roche assay or abbott assay.

• 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: 6954083
• MDR Text Key: 90654957
• Report Number: 1823260-2017-02341
• 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,Followup
• Report Date: 11/01/2017

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: 225150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/17/2017
• Supplement Dates Manufacturer Received: 10/03/2017
• Supplement Dates FDA Received: 11/01/2017
• 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