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 01/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This event occurred in (b)(6).

Event Description

The customer complained of erroneous free thyroxine (ft4 ii) for 2 patients.Based on the data provided, erroneous ft3 - free triiodothyronine (ft3) results were also identified for 1 patient.Comparisons were being performed between an e602 analyzer and a dialysis method from another laboratory.The dialysis method results are believed to be correct.It is not known if any erroneous results were reported outside of the laboratory for patient 1.The erroneous ft4 ii results were reported outside of the laboratory for patient 2.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(4) for information on the ft3 erroneous results.Patient 1 initial ft4 ii result from the e602 analyzer was 56.9 pmol/l.The repeat ft4 ii result using the dialysis method was 12 pmol/l.The initial ft3 result from the e602 analyzer was 24.3 pmol/l.The repeat ft3 result using the dialysis method was 6.9 pmol/l.On (b)(6) 2016 patient 2 (male, (b)(6) years old) had an ft4 ii result from the e602 analyzer was 64.6 pmol/l.This result did not fit the clinical status of the patient.On (b)(6) 2016 the initial ft4 ii result from the e602 analyzer was 72.3 pmol/l.This result was reported outside of the laboratory where it was questioned by the physician.The repeat ft4 ii result using the dialysis method was 14.0 pmol/l.No adverse event was reported for either patient.The e602 analyzer serial number was (b)(4).

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.

Manufacturer Narrative

An additional ft4ii result from (b)(6) 2016 was provided for patient 1 of 50.5 pmol/l.On (b)(6) 2016 a new sample was obtained for patient 2 and the tsh result was 1.2 mu/l, the ft4 ii result was 51.4 pmol/l and the ft3 result was 22.0 pmol/l.On (b)(6) 2016 a new sample was obtained for patient 1 and the tsh result was 0.97 mu/l, the ft4ii result was 86.6 pmol/l and the ft3 result was 26.9 pmol/l.

Manufacturer Narrative

Samples for each patient were submitted for investigation.During the investigation, a pre-wash interference was confirmed which indicates the potential for an interferent.This interferent most likely caused the high ft4 ii and ft3 iii results.Interferences are documented in product labeling.

• 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: 5610887
• MDR Text Key: 43780986
• Report Number: 1823260-2016-00497
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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,Followup
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• 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
• Date Manufacturer Received: 04/07/2016
• 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: 12 YR