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 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event occurred in: (b)(6).

Event Description

The customer received questionable thyroid results for 2 patient samples tested on both a cobas 6000 e 601 module (serial number not provided) and a cobas e 411 immunoassay analyzer serial number (b)(4).Of the data provided for patient #1, the results for elecsys ft4 ii assay, elecsys ft3 iii, elecsys t4 assay, and elecsys t3 are reportable malfunctions.Patient #1 had two separate samples collected, one on (b)(6) 2107 (sample a) and another on (b)(6) 2017 (sample b).Sample b had additional testing performed in another laboratory on a siemens-immulite 2000xpi, abbott-architect, and a beckman coulter.Of the data provided for patient #2, the results for elecsys ft4 ii assay and elecsys tsh assay are reportable malfunctions.Patient #2 is a (b)(6) female with a date of birth that was not provided.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 ii erroneous results, medwatch with patient identifier (b)(6) for information on the t3 erroneous results, medwatch with patient identifier (b)(6) for information on the t4 erroneous results, and medwatch with patient identifier (b)(6) for information on the tsh erroneous results.The erroneous results were not reported outside of the laboratory.There was no allegation of an adverse event.On the day of event the customer stated qc results were acceptable.The customer believes the results from the cobas e411 were correct.The investigation is currently ongoing.

Manufacturer Narrative

Other relevant history updated.

Manufacturer Narrative

For patient #1 a sample was received for further investigation.The tsh, ft4, ft3, t4, and t3 values generated at the customer site were confirmed.Upon further analysis an interfering factor was detected.This most likely caused the falsely elevated values of the ft4ii, ft3iii, and t4 and an increase value of t3.This interference is covered in product labeling.Product labeling states "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The incidence rate of the identified interfering factor is monitored on a quarterly basis.For patient #2 there was insufficient amount of sample remaining, so further analysis could not be performed.A specific root cause could not be determined.

• 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: 7139334
• MDR Text Key: 95825719
• Report Number: 1823260-2017-03099
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: HR
• 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,Followup
• Report Date: 01/25/2018

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: 265631
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 12/05/2017; 12/05/2017
• Supplement Dates FDA Received: 01/05/2018; 01/25/2018
• 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